Medtronic Neuromodulation
FDA adverse event reports naming Medtronic Neuromodulation as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: MEDTRONIC NEUROMODULATION.
- Total reports
- 58,673
- Deaths
- 776
- Injuries
- 32,233
- Malfunctions
- 25,578
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Pump, Infusion, Implanted, ProgrammableLKK16,929
- Stimulator, Electrical, Implantable, For IncontinenceEZW13,739
- Stimulator, Spinal-Cord, Totally Implanted For Pain ReliefLGW13,594
- Stimulator, Electrical, Implanted, For Parkinsonian TremorMHY11,402
- Intestinal StimulatorLNQ781
- Implanted Subcortical Electrical Stimulator (Motor Disorders)MRU652
- Permanent Pacemaker ElectrodeDTB227
- Stimulator, Spinal-Cord, Implanted (Pain Relief)GZB130
- Stimulator, Electrical, Implanted, For Essential TremorPJS122
- Stimulator, Brain, Implanted, For Behavior ModificationMFR114
Recent recalls
- 2026-05-28Open, ClassifiedUnder Investigation by firm
Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
- 2026-05-28Open, ClassifiedUnder Investigation by firm
Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
A limited number of Pocket Adaptor Kits, Model 64001 and 64002, are labeled with incorrect Use-By-Dates.
- 2026-05-14Open, ClassifiedUnder Investigation by firm
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software Application, loaded on the following devices: 1. PROG CT900A CLINICIAN TABLET US, Model Number CT900A; 2. PROG CT900B CLINICIAN TABLET EU -UK, Model Number CT900B; 3. PROG CT900C CLINICIAN TABLET UK, Model Number CT900C; 4. PROG CT900D CLINICIAN TABLET GLOBAL, Model Number CT900D; 5. PROG CT900E CLINICIAN TABLET GLBL SMSNG, Model Number CT900E; 6. PROG CT900F CLINICIAN TABLET GLBL SMSNG, Model Number CT900F; implanted programmable infusion pump
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
- 2026-01-09Open, ClassifiedSoftware design
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
- 2025-12-23Open, ClassifiedSoftware design
Restore Clinician Programmer Application (CP App), Model A71100 used with the following programmers: CT900A PROG CT900A CLINICIAN TABLET US CT900B PROG CT900B CLINICIAN TABLET EU -UK CT900C PROG CT900C CLINICIAN TABLET UK CT900D PROG CT900D CLINICIAN TABLET GLOBAL CT900E PROG CT900E CLINICIAN TABLET GLBL SMSNG CT900F PROG CT900F CLINICIAN TABLET GLBL SMSNG
Software issue where a Device Reset message displayed on the app was unable to be cleared. In rare cases, this resulted in an inability to resume therapy, and the patient experienced a recurrence of underlying pain symptoms. Resolution would require surgical replacement of the INS.
- 2025-04-30Open, ClassifiedDevice Design
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.
- 2025-04-08Open, ClassifiedUnder Investigation by firm
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis Pro (Model 977118) neurostimulators
There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative programming sequence is used.
- 2025-04-01Open, ClassifiedUnder Investigation by firm
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
- 2024-12-27Open, ClassifiedUnder Investigation by firm
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
Software issues were identified in application version 2.x.
- 2024-12-27Open, ClassifiedUnder Investigation by firm
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900C CLINICIAN TABLET UK with the A810 CP app version 2.x, CFN CT900C
Software issues were identified in application version 2.x.
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