Proclaim™ 5 EliteRecalls & reported problems
St. Jude Medical, Inc. · Implantable Pulse Generator · Class 3 · Implant
All models of Proclaim (12)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This St. Jude Proclaim 5 Elite spinal cord stimulator is named in 9,650 adverse event reports, including 10 deaths and 8,077 injuries. The reports mostly describe pain relief falling short, battery and wireless problems, and implants removed or replaced after discomfort or lead damage. One open recall, from May 2024, concerns a shorter time between the battery replacement warning and end of service than the labeling states.
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
- 9,661
- Deaths reported
- 10
- Injuries reported
- 8,090
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 9,661 adverse event reports that list this exact device (DI 05415067020192), received between Jun 9, 2018 and Sep 29, 2026 — classified as 10 deaths, 8,090 injuries, 1,561 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (1,920 reports).
1 FDA recall record name this device's identifier, 1 still open.
14 other recalls cover devices cleared under the same FDA submission (P010032); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Recalls naming this device
- May 16, 2024Open, Classified
The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
Z-2369-2024 · Root cause: Vendor change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2,355
- Battery Problem1,920
- Wireless Communication Problem1,696
- Insufficient Device Problem Information1,261
- Premature Elective Replacement Indicator1,120
- Therapeutic or Diagnostic Output Failure400
- Application Program Freezes or Fails to Launch329
- No Device Output187
Patient problems
- Inadequate Pain Relief5,339
- No Consequences Or Impact To Patient1,217
- Failure of Implant961
- Implant Pain699
- Pain527
- No Clinical Signs, Symptoms or Conditions525
- Discomfort384
- No Known Impact Or Consequence To Patient335
Recent adverse event reports
The 25 most recent of 9,661 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Insufficient Device Problem Information
It was reported the patient is going to undergo an explant for an unknown reason. Further information is not available.
Patient problems: Insufficient Information
MAUDE report 50936147 ↗InjurySep 29, 2026Insufficient Device Problem Information
It was reported the patient's IPG reached end of life. It is unknown if this occurred prematurely. Surgical intervention took place where the IPG was replaced and therapy was restored.
Patient problems: Inadequate Pain Relief
MAUDE report 50935630 ↗InjurySep 29, 2026Insufficient Device Problem Information
It was reported patient underwent surgical intervention at an unknown time wherein the entire system was explanted to address an unknown issue.
Patient problems: Insufficient Information
MAUDE report 50935148 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Implant Pain
MAUDE report 50925103 ↗InjurySep 28, 2026Migration
It was reported that the patient experienced ineffective therapy, uncomfortable stimulation, and pain at the IPG site. Troubleshooting revealed patient's IPG flipped in pocket and the leads migrated. As a result, surgical intervention was undertaken on (b)(6) 2026 wherein the system was explanted and replaced to address the issue. Effective therapy was restored post-operatively.
Patient problems: Implant Pain
MAUDE report 50916637 ↗InjurySep 25, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50902938 ↗InjurySep 22, 2026Wireless Communication Problem
It was reported that following an unrelated surgical procedure wherein the device was not placed into surgery mode, the IPG became unable to communicate with external devices. Troubleshooting was unable to resolve the issue. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50856010 ↗InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem
It was reported that following significant weight loss, the patient experienced pain at the IPG site. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Implant Pain
MAUDE report 50855405 ↗InjurySep 22, 2026Wireless Communication Problem
It was reported that following an unrelated surgical procedure wherein the device was not placed into surgery mode, the IPG became unable to communicate with external devices. Troubleshooting has been unable to resolve the issue. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50849989 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported patient experienced discomfort at implant site due to size and location of IPG. Surgical intervention may be pending to address the issue.
Patient problems: Implant Pain
MAUDE report 50828433 ↗InjurySep 16, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50796632 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced discomfort at the IPG site. As a result, surgical intervention may be undertaken to address the issue.
Patient problems: Implant Pain
MAUDE report 50791915 ↗InjurySep 14, 2026Insufficient Device Problem Information
It was reported that the patient¿s IPG was explanted and replaced with a competitor¿s IPG. The reason for explant and date of explant is unknown.
Patient problems: Insufficient Information
MAUDE report 50760895 ↗InjuryAug 27, 2026Insufficient Device Problem Information
It was reported that the patient had their IPG explanted on an unknown date for an unknown reason.
Patient problems: Inadequate Pain Relief
MAUDE report 50476309 ↗InjuryAug 26, 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 50463541 ↗InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient developed an infection. As a result, the SCS system was surgically removed. Date of explant is unknown. Patient has now completely recovered
Patient problems: Unspecified Infection
MAUDE report 50260376 ↗InjuryAug 6, 2026Insufficient Device Problem Information
It was reported that the patient had their system explanted in (b)(6) 2024 for an unknown reason.
Patient problems: Insufficient Information
MAUDE report 50164456 ↗InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported that following recent weight loss, the patient experienced pain at the IPG site. As a result, surgical intervention was undertaken on (b)(6)2026 wherein the IPG was explanted and replaced to address the issue.
Patient problems: Implant Pain
MAUDE report 50131538 ↗InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an infection. As a result, surgical intervention was undertaken at an unknown date in 2025, during which the system was explanted to address the issue.
Patient problems: Unspecified Infection
MAUDE report 50129395 ↗InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the patient experienced an infection. As a result, surgical intervention was undertaken at an unknown date in 2025, during which the system was explanted to address the issue.
Patient problems: Unspecified Infection
MAUDE report 50129384 ↗InjuryAug 3, 2026Insufficient Device Problem Information
It was reported that the patient had their IPG explanted on an unknown date for an unknown reason.
Patient problems: Insufficient Information
MAUDE report 50114375 ↗InjuryJul 31, 2026Wireless Communication Problem
It was reported that following an unrelated surgical procedure wherein the device was placed into surgery mode, the IPG became unable to communicate with external devices. Troubleshooting was unable to resolve the issue. As a result, surgical intervention maybe undertaken to address the issue.
Patient problems: Inadequate Pain Relief
MAUDE report 50104335 ↗InjuryJul 29, 2026Temperature Problem
It was reported that during an MRI while MRI mode was enabled patient experienced a burning sensation at the IPG site. As a result, MRI was aborted to address the issue. Symptoms resolved shortly after.
Patient problems: Burning Sensation
MAUDE report 50073191 ↗InjuryJul 27, 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 50031690 ↗InjuryJul 13, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AT THE IPG SITE. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED AT A NEW POCKET SITE.
Patient problems: Implant Pain
MAUDE report 25803891 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P010032. One submission often covers many models, so check the product and lot details in each record.
- Z-0458-2026 · Oct 6, 2025 · Open, ClassifiedEterna SCS IPG (Implantable Pulse Generator), Model Number 32400
- Z-2509-2023 · Jul 18, 2023 · Open, ClassifiedProclaim DRG Implantable Pulse Generator REF 3664 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extens
- Z-2506-2023 · Jul 18, 2023 · Open, ClassifiedProclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device
- Z-2507-2023 · Jul 18, 2023 · Open, ClassifiedProclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
- Z-2505-2023 · Jul 18, 2023 · Open, ClassifiedProclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electr
- Z-2508-2023 · Jul 18, 2023 · Open, ClassifiedProclaim Plus 7 Implantable Pulse Generator REF 3672 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more ext
- Z-2511-2023 · Jul 18, 2023 · Open, ClassifiedInfinity 7 Implantable Pulse Generator REF 6662 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
- Z-2510-2023 · Jul 18, 2023 · Open, ClassifiedInfinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio
- Z-2692-2017 · Jun 2, 2017 · TerminatedProclaim 7 Elite, Implantable Pulse Generator, REF 3662, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c
- Z-2691-2017 · Jun 2, 2017 · TerminatedProclaim 5 Elite, implantable Pulse Generator, REF 3660, Rx only, STERILE EO Product Usage: The Proclaim implantable pulse generator (IPG) is an electronic device designed to be c
- Z-1785-2013 · Nov 30, 2012 · TerminatedEon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 reca
- Z-0025-2013 · Sep 4, 2012 · TerminatedThe Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode
- Z-1738-2013 · Jul 26, 2012 · TerminatedEon - 3701 (Wall Charger) and 3711 (Portable Charger). Product Usage: Eon: Eon system is indicated as an aid in the management of chronic intractable pain of the trunk and/or li
- Z-3091-2011 · Jun 2, 2009 · TerminatedSoftware version 3.3 for Rapid Programmer devices, Model 3832. Software version 3.3 for Rapid Programmer devices, a personal digital assistant (PDA) based programmer supporting im
Other STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF devices
- Octrode™ 3186St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF30 deaths32,096 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 deaths23,976 reports
- RestoreSensor™SureScan® 97714Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF6 deaths17,903 reports
- Proclaim™ 3660St. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF2 recalls25 deaths13,336 reports
- Intellis™ AdaptiveStim® 97715Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF11,487 reports
- Precision Spectra ™ SC-1132Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF53 deaths11,269 reports
- Proclaim™ 7 EliteSt. Jude Medical, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF1 recall12 deaths7,299 reports
- Spectra WaveWriter™ SC-1160Boston Scientific Neuromodulation Corporation · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF31 deaths7,221 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page