Infinity™ 7 (REF 6663)Recalls & reported problems
St. Jude Medical, Inc. · Implantable Pulse Generator · Class 3 · Implant
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This St. Jude Medical Infinity 7 implantable pulse generator is a surgically implanted device that sends electrical pulses to treat Parkinsonian tremor. The 47 reports mostly describe batteries running down sooner than expected, prompting surgery to remove and replace the generator, along with tremor returning and inadequate pain relief; 1 death and 44 injuries were reported. One open recall, started in May 2024, says the replacement indicator and end-of-service date may come sooner than the labeling states, potentially ending therapy.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 47
- Deaths reported
- 1
- Injuries reported
- 44
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 05415067020277), received between Jun 13, 2018 and May 14, 2026 — classified as 1 death, 44 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (25 reports).
1 FDA recall record name this device's identifier, 1 still open.
5 other recalls cover devices cleared under the same FDA submission (P140009); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- May 22, 2024Open, Classified
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.
Z-2432-2024 · Root cause: Error in labeling · FDA record ↗
Most reported problems
Device problems
- Battery Problem25
- Insufficient Device Problem Information10
- Adverse Event Without Identified Device or Use Problem7
- High impedance1
- Impedance Problem1
- Manufacturing, Packaging or Shipping Problem1
- No Apparent Adverse Event1
- Premature Discharge of Battery1
Patient problems
- Inadequate Pain Relief16
- Failure of Implant13
- Movement Disorder10
- No Clinical Signs, Symptoms or Conditions7
- Insufficient Information4
- Hypersensitivity/Allergic reaction2
- Unspecified Infection2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 47 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT HAD THEIR SYSTEM EXPLANTED ON AN UNKNOWN DATE FOR AN UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25175524 ↗InjuryMar 2, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT IS PENDING SURGICAL INTERVENTION FOR A IPG REPLACEMENT FOR AN UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 24480076 ↗InjuryJan 22, 2026Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT'S IPG WAS EXPLANTED AT AN UNKNOWN DATE FOR AN UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Insufficient Information
MAUDE report 24157969 ↗InjuryNov 23, 2025No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT RECEIVED A LOW BATTERY WARNING. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23627655 ↗InjuryNov 6, 2025Premature Discharge of Battery; Premature Discharge of Battery
IT WAS REPORTED THAT THE PATIENT RECEIVED A LOW BATTERY WARNING. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2025 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23490480 ↗InjuryJul 10, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT'S IPG HAS REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION OCCURRED WHERE THE IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2025. REPORTEDLY, THERAPY WAS RESTORED AFTER SURGERY.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 22472370 ↗InjuryJun 2, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 22128131 ↗InjuryMay 16, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT'S IPG HAS REACHED END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 22033379 ↗InjuryMay 10, 2025Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT'S IPG REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 21999707 ↗InjuryMar 13, 2025Battery Problem; Battery Problem
IT WAS REPORTED PATIENT LOST THERAPY AND IPG WAS FOUND TO BE END OF LIFE. AS SUCH SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS REPLACED, AND THERAPY WAS RESTORED.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 21602032 ↗InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED TO ADDRESS THE ISSUE.
Patient problems: Unspecified Infection
MAUDE report 21146028 ↗InjuryNov 13, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED A LOW BATTERY WARNING. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE IPG WAS EXPLANTED AND REPLACED.
Patient problems: Failure of Implant
MAUDE report 20679243 ↗InjuryNov 8, 2024Battery Problem; Battery Problem
IT WAS REPORTED THE PATIENT LOST THERAPY AS THE IPG REACHED END OF SERVICE (EOS). IT IS UNKNOWN IF THE IPG DEPLETED PREMATURELY. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS CONFIRMED.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 20641751 ↗InjurySep 9, 2024Battery Problem; Battery Problem
IT WAS REPORTED PATIENT LOST THERAPY DUE TO IPG REACHING END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. THERAPY WAS RESTORED POST-OP.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 20177381 ↗InjuryAug 14, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT RECEIVED A LOW BATTERY WARNING. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.
Patient problems: Failure of Implant
MAUDE report 19988226 ↗InjuryMay 7, 2024Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT'S IPG REACHED THE END OF ITS SERVICE. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST PROCEDURE.
Patient problems: Failure of Implant; Movement Disorder
MAUDE report 19264362 ↗InjuryMar 19, 2024Impedance Problem; Impedance Problem
IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE FALLS AND LEADING TO IMPEDANCE ISSUE. AS SUCH THE IPG WAS REPLACED, AND THERAPY WAS RESTORED FOLLOWING THE PROCEDURE.
Patient problems: Movement Disorder
MAUDE report 18935070 ↗DeathJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPIRED. THERE IS NO KNOWN ALLEGATION FROM A HEALTHCARE PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE CAUSE OF DEATH WAS SEPTIC SHOCK.
Patient problems: Septic Shock
MAUDE report 18551096 ↗InjuryJun 23, 2023Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT¿S IPG HAD REACHED END OF LIFE. IT IS UNKNOWN IF THIS OCCURRED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE IPG WAS EXPLANTED AND REPALCED TO ADDRESS THE ISSUE.
Patient problems: Failure of Implant; Inadequate Pain Relief; Movement Disorder; Shaking/Tremors
MAUDE report 17188774 ↗InjuryDec 23, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT'S IPG HAD REACHED END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 16043223 ↗InjuryNov 18, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE PATIENT UNDERWENT A UNKNOWN EXPLANT FOR A UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: Insufficient Information
MAUDE report 15825672 ↗InjuryNov 16, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT THE PATIENT'S IPG HAD REACHED END OF LIFE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE IPG WAS EXPLANTED AND REPLACED.
Patient problems: Inadequate Pain Relief
MAUDE report 15804768 ↗InjuryOct 1, 2022Battery Problem; Battery Problem
IT WAS REPORTED THAT PATIENT CONTROLLER DISPLAYED THE ELECTIVE REPLACEMENT INDICATOR (ERI). SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED.
Patient problems: Inadequate Pain Relief
MAUDE report 15522774 ↗InjurySep 30, 2022Battery Problem; Battery Problem
IT WAS REPORTED THE PATIENT'S IPG REACH END OF LIFE. IT IS UNKNOWN IF THE IPG DEPLETED PREMATURELY. AS A RESULT, THE IPG WAS REPLACED TO ADDRESS THE ISSUE.
Patient problems: Inadequate Pain Relief
MAUDE report 15514200 ↗InjurySep 12, 2022Battery Problem; Battery Problem
IT WAS REPORTED THE DEVICE DISPLAYED THE END OF SERVICE (EOS) MESSAGE AND IT IS UNKNOWN IF THE DEVICE DEPLETED PREMATURELY. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS RESTORED POST OPERATIVELY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15402695 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P140009. One submission often covers many models, so check the product and lot details in each record.
- Z-0459-2026 · Oct 6, 2025 · Open, ClassifiedLiberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400
- Z-2693-2017 · Jun 2, 2017 · TerminatedInfinity 5, Implantable Pulse Generator, REF 6660, Rx only, STERILE EO, Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions.
- Z-2694-2017 · Jun 2, 2017 · TerminatedInfinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I
- Z-2696-2017 · Jun 2, 2017 · TerminatedInfinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I
- Z-2695-2017 · Jun 2, 2017 · TerminatedInfinity 7, Implantable Pulse Generator, REF 6662, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. I
Other STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR devices
- Activa® RC 37612Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 deaths1,849 reports
- Activa® 37603Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR8 deaths1,093 reports
- Infinity™ 6662St. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall3 deaths803 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall3 deaths751 reports
- Activa® SC 37603Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR1 recall1 death443 reports
- Infinity™ 7St. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR2 recalls3 deaths368 reports
- St. Jude Medical Infinity™ DBS SystemSt. Jude Medical, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR406 reports
- Activa® RC 37612Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian tremor2 deaths371 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.