MAUDE Adverse Event Report: ABBOTT MEDICAL SCS RECHARGEABLE IPG; PRODIGY IPG

Model Number	3799
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The unique device identifier (udi) is not provided because the lot number is unknown.Initial reporter phone number: (b)(6).
Event or Problem Description
It was reported that the patient's ipg had become inoperable.As a result, the patient may undergo surgical intervention to address the issue.
Additional Manufacturer Narrative
Section b1 product problem should no longer be checked off given the additional information.
Event or Problem Description
Additional information received indicates that the ipg became inoperable due to the patient not recharging their device as recommended.As a result, the patient underwent surgical intervention during which the ipg was explanted and replaced with no complications.
Additional Manufacturer Narrative
Correction: section d2a, d4, and h4 information should have been updated in additional report 1.This correction is reflected in this additional report 2.
Additional Manufacturer Narrative
A patient experiencing a recharge burden was reported to abbott.The patient¿s ipg was explanted and replaced.Therapy was restored.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 could not be conclusively determined.
Additional Manufacturer Narrative
The reported event for explant due to patient being unable to charge the ipg was confirmed.As received, the ipg was inoperable due to a depleted battery as patient had a charging issue.The battery was recovered and the ipg communicated, charged, and was tested to manufacturing specifications using the autotester.The ipg was functionally tested and passed all testing.

• Brand Name: SCS RECHARGEABLE IPG
• Common Device Name: PRODIGY 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19421654
• Report Number: 1627487-2024-09011
• Device Sequence Number: 15481212
• Product Code: LGW
• UDI-Device Identifier: 05414734405485
• UDI-Public: (01)05414734405485(10)5416704(17)180310
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/08/2025

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: 03/10/2018
• Device Model Number: 3799
• Device Catalogue Number: 3799
• Device Lot Number: 5416704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: 08/23/2024; 09/20/2024; 09/25/2024; 12/27/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 09/18/2024; 09/20/2024; 10/01/2024; 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female