Prodigy™ 3799Recalls & reported problems

Summary

The FDA's MAUDE database contains 142 adverse event reports that list this exact device (DI 05414734405485), received between Jul 3, 2018 and Jun 23, 2026 — classified as 141 injuries, 1 malfunction.

The most frequently reported specific device problem is “Wireless Communication Problem” (46 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 142 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2026Improper or Incorrect Procedure or Method; Wireless Communication Problem

  IT WAS REPORTED THE IPG WAS UNABLE TO COMMUNICATE WITH THE EXTERNAL DEVICES. THE PATIENT DID NOT RECHARGE THE IPG AS RECOMMENDED. AS SUCH, THE IPG BECAME INOPERABLE. SURGICAL INTERVENTION MAY BE PENDING TO ADDRESS THIS SITUATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 25597708 ↗
• InjuryApr 6, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT HAD NOT USED THE IPG FOR AN EXTENDED PERIOD OF TIME, RENDERING THE IPG INOPERABLE. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. AS SUCH, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24791508 ↗
• InjuryApr 3, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENTS IPG WAS EXPLANTED AND REPLACED ON (B)(6) 2023 FOR AN UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 24779711 ↗
• InjuryDec 19, 2025No Apparent Adverse Event; Wireless Communication Problem; No Apparent Adverse Event; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT¿S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND THE IPG DEEMED INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. THERAPY WAS RESTORED POST-OP.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23853961 ↗
• InjuryDec 5, 2025Insufficient Device Problem Information; Wireless Communication Problem; Insufficient Device Problem Information; Wireless Communication Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THE PATIENT'S IPG WAS REPLACED DUE TO BEING INOPERABLE.

  Patient problems: Inadequate Pain Relief; Insufficient Information

  MAUDE report 23731739 ↗
• InjuryNov 25, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT DID NOT CHARGE THEIR IPG AS RECOMMENDED AND THE IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23650439 ↗
• InjuryNov 14, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT¿S IPG WAS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. A MANUFACTURER REPRESENTATIVE CONFIRMED THE ISSUE AND THE IPG DEEMED INOPERABLE. SURGICAL INTERVENTION MAY BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 23560236 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND SHOCKING AT THE IPG SITES, AND INEFFECTIVE THERAPY. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN TO ADDRESS THE ISSUE.

  Patient problems: Implant Pain; Undesired Nerve Stimulation

  MAUDE report 23491022 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED WHEREIN THE IPG WAS EXPLANTED TO ADDRESS THE ISSUE.

  Patient problems: Pocket Erosion

  MAUDE report 23288773 ↗
• InjuryJul 24, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED. EFFECTIVE THERAPY WAS CONFIRMED.

  Patient problems: Failure of Implant; Inadequate Pain Relief

  MAUDE report 22586038 ↗
• InjuryJun 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THAT PATIENT UNDERWENT SURGICAL INTERVENTION AT UNKNOWN DATE FOR UNKNOWN REASON WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 22171622 ↗
• InjuryJun 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT¿S IPG WAS EXPLANTED AND REPLACED WITH A COMPETITOR¿S IPG FOR AN UNKNOWN REASON. THE DATE OF EXPLANT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 22164686 ↗
• InjuryFeb 3, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT STOPPED CHARGING THE IPG DUE TO THE LEAD ISSUE (RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2022-00052 AND 1627487-2022-00053). AS SUCH, THE IPG BECAME INOPERABLE. IN TURN, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, EFFECTIVE THERAPY WAS RESTORED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21289824 ↗
• InjuryJan 7, 2025Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT FOLLOWING ECG PROCEDURE, THE PATIENT WAS UNABLE CONNECT TO THE IPG TO TURN THERAPY ON. REPLACEMENT CHARGER/PROGRAMMER WAS UNABLE TO COMMUNICATE/RESOLVE THE ISSUE. AS SUCH, THE IPG IS INOPERABLE. IN TURN, SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21093091 ↗
• InjuryDec 26, 2024Wireless Communication Problem; Wireless Communication Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 21019671 ↗
• InjuryNov 21, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PATIENT STOPPED CHARGING THEIR IPG DUE TO RECHARGE BURDEN, RENDERING THE IPG INOPERABLE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE. REPORTEDLY, THERAPY WAS RESTORED POST OP. THE REPORTED DEVICE WAS DISCARDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20746251 ↗
• InjuryOct 4, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT PATIENTS IPG BECAME UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2024 WHEREIN IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20377849 ↗
• InjurySep 13, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THE PATIENT'S IPG WAS INOPERABLE. SURGICAL INTERVENTION WAS UNDERTAKEN DURING WHICH THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 20213934 ↗
• InjurySep 13, 2024Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213235 ↗
• InjuryMay 29, 2024Improper or Incorrect Procedure or Method; Wireless Communication Problem; Improper or Incorrect Procedure or Method; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG HAD BECOME INOPERABLE. AS A RESULT, THE PATIENT MAY UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19421654 ↗
• InjuryMay 20, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE IPG FAILED TO ESTABLISH COMMUNICATION WITH EXTERNAL DEVICES. THE IPG WAS DEEMED INOPERABLE, AND PATIENT LOST THERAPY. SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN IPG AS EXPLANTED AND REPLACED TO ADDRESS THE ISSUE.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19356063 ↗
• InjuryApr 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT HAD A SERIES OF REVISIONS WITH THEIR SCS SYSTEM. THE SPECIFIC DATES OR ISSUES LEADING TO REVISION WERE NOT SPECIFIED. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19127541 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED DUE TO AN INFECTION. IT WAS NOTED THAT THE DEVICE WAS STARTING TO ERODE THROUGH THE SKIN AND MAKE THE PATIENT ILL. NO OTHER INFORMATION IS KNOWN.

  Patient problems: Skin Erosion; Unspecified Infection

  MAUDE report 19126873 ↗
• InjuryApr 7, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT'S IPG HAD BECOME INOPERABLE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION DURING WHICH THE IPG WAS EXPLANTED AND REPLACED WITH NO COMPLICATIONS.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19057118 ↗
• InjuryApr 4, 2024Wireless Communication Problem; Wireless Communication Problem

  IT WAS REPORTED THAT THE PATIENT LOST THERAPY DUE TO IPG BEING INOPERABLE. REPORTEDLY, THE PATIENT WENT EXTENDED PERIOD OF TIME WITHOUT CHARGING THE IPG, RENDERING THE IPG INOPERABLE. TROUBLESHOOTING WAS UNABLE TO RESOLVE THE ISSUE. AS SUCH, SURGICAL INTERVENTION TOOK PLACE WHEREIN THE IPG WAS EXPLANTED AND REPLACED WITH A NEW IPG TO ADDRESS THE ISSUE. REPORTEDLY, THERAPY WAS CONFIRMED POST OP.

  Patient problems: Inadequate Pain Relief

  MAUDE report 19044922 ↗

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, Classified
  Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
• Z-2505-2023 · Jul 18, 2023 · Open, Classified
  Proclaim 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-2511-2023 · Jul 18, 2023 · Open, Classified
  Infinity 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, Classified
  Infinity 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-2508-2023 · Jul 18, 2023 · Open, Classified
  Proclaim 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-2507-2023 · Jul 18, 2023 · Open, Classified
  Proclaim 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-2509-2023 · Jul 18, 2023 · Open, Classified
  Proclaim 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, Classified
  Proclaim" 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-2692-2017 · Jun 2, 2017 · Terminated
  Proclaim 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 · Terminated
  Proclaim 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 · Terminated
  Eon 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 · Terminated
  The 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 · Terminated
  Eon - 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 · Terminated
  Software 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