Stimulator, Electrical, Implanted, For Parkinsonian Tremor
FDA adverse event reports and recall history for stimulator, electrical, implanted, for parkinsonian tremor (product code MHY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 52,642
- Deaths
- 721
- Injuries
- 25,185
- Malfunctions
- 26,507
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.
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.
- 2025-11-07Open, ClassifiedProcess control
Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), Model 32400 and Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), Model 62400 . These devicess may experience a loss of communication with the Clinician Programmer (CP) and/or the Patient Controller (PC).
- 2024-10-23Open, ClassifiedUnder Investigation by firm
Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer Application upon use and an "Invalid Device" message will appear.
- 2024-07-25Open, ClassifiedError in labeling
Abbott Infinity 5, Implantable Pulse Generator, REF: 6660, SterileEO, Rx Only
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
- 2024-07-25Open, ClassifiedError in labeling
Abbott Infinity 5, Implantable Pulse Generator, REF: 6661, SterileEO, Rx Only
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
- 2024-07-25Open, ClassifiedError in labeling
Abbott Infinity 7, Implantable Pulse Generator, REF: 6662, SterileEO, Rx Only
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
- 2024-07-25Open, ClassifiedError in labeling
Abbott Infinity 7, Implantable Pulse Generator, REF: 6663, SterileEO, Rx Only
Their is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product labeling potentially resulting in loss of therapy.
- 2024-07-24Open, ClassifiedUnder Investigation by firm
A610 Clinician Programmer (CP) Software Application (app) with the following versions: Version 2.0.x (2.0.4584, 2.0.4594, 2.0.4605, 2.0.4630, and 2.0.4648), Version 3.0.x (3.0.1057, 3.0.1062, 3.0.1081, and 3.0.1098), Version 4.0.x (4.0.1052). Includes the below product descriptions: 1. ADAPTOR 64001 1X4 MVMT POCKET ADAPTOR, 2. ADAPTOR 64002 2X4 MVMT POCKET ADAPTOR, 3. INS 37602 Activa SC Neurostimulator, 4. INS 37603 Activa SCx Neurostimulator, 5. INS B35200 DBS PERCEPT PC, 6. INS B35300 PERCEPT RC V1
Patients implanted with a pocket adaptor (Model 64001 and/or 64002) are limited to HEAD ONLY MRI eligibility.
- 2024-07-03Open, ClassifiedSoftware design
Abbott Liberta RC, Implantable Pulse Generator, REF: 62400, STERILE, RxONLY
Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.
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