MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number	3716
Medical Device Problem Codes	Battery Problem (2885); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that both patient's ipgs had reached end of life.It is unknown if this occurred prematurely.As a result, surgical intervention was undertaken wherein both ipgs were explanted and replaced to address the issue.Therapy was restored post-op.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event is consistent with the battery reaching end of life.
Additional Manufacturer Narrative
Corrected: d4 - additional device information corrected: d6a - date of implant corrected: d10.
Event or Problem Description
Additional information indicated the ipgs met or exceeded 75% expected longevity.There is no device malfunction.
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported event is consistent with the battery reaching end of life.

• Brand Name: PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR
• Common Device Name: SCS IPG
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: sara speyerer ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 22851349
• Report Number: 1627487-2025-04142
• Device Sequence Number: 19938241
• Product Code: LGW
• UDI-Device Identifier: 05414734402583
• UDI-Public: (01)05414734402583(10)3763718(17)140728
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2014
• Device Model Number: 3716
• Device Catalogue Number: 3716
• Device Lot Number: 3763718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 08/21/2025; 09/09/2025; 09/12/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 08/28/2025; 09/10/2025; 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS ANCHOR 2X; SCS LEAD 2X; SCS LEAD 2X
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 86 KG