Stimulator, Spinal-Cord, Implanted (Pain Relief)
FDA adverse event reports and recall history for stimulator, spinal-cord, implanted (pain relief) (product code GZB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 43,921
- Deaths
- 196
- Injuries
- 41,428
- Malfunctions
- 1,801
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
- 2014-09-29TerminatedPackaging process control
Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
- 2014-09-29TerminatedPackaging process control
Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
The Directions for Use (DFU) manual contains information for devices that are not approved in the US. The correct US approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
- 2010-04-21TerminatedOther
Swift-Lock (TM) Anchor Accessory Kit, Directions For Use Model 1192, ANS, A St. Jude Medical Company. Product is intended to be used as an accessory to the leads component of ANS SCS systems, functioning to secure the lead to the fascia or interspinous/supraspinous ligament.
Directions For Use of product incorrectly stated lead compatibility information.
- 2008-09-18TerminatedSoftware design (manufacturing process)
Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto Rico, USA. Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide. Model 3998 lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord. The lead consists of two polyurethane lead bodies joined to one silicone rubber paddle. The lead has two parallel rows of four platinum iridium electrodes on the distal end.
Medtronic is recalling certain lots of Model 3998 SPECIFY surgical lead kits due to a package mislabeling issue. The package labeling incorrectly states the lead length is 28 cm in length when it should state 20 cm. Recalled lots are to be returned for replacement or credit.
- 2006-05-25TerminatedOther
Medtronic Model 37711 Restore Neurostimulator. The Restore Neurostimulator is an implanted, rechargeable neurostimulator which provides pain management therapy.
A limited number of Model 37711 Restore Neurostimulators have an incorrect internal memory parameter that causes the device to indicate it is fully recharged when it may only be 80% to 90% recharged. This anomaly does not affect patient safety. This anomoly can be corrected by reprogramming the Restore Neurostimulator using specific software.
Monitor stimulator, spinal-cord, implanted (pain relief) automatically
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