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

Model Number	3799
Medical Device Problem Code	Wireless Communication Problem (3283)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Date of implant is unknown.Initial reporter phone number: (b)(6).During processing of this incident, attempts were made to obtain complete device information.Further information was requested but not received.
Event or Problem Description
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.
Additional Manufacturer Narrative
The reported event for inoperable ipg was confirmed.As received, the ipg was inoperable due to a depleted battery.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.Additionally, the device history record of the device was reviewed to confirm that all manufacturing steps were completed and there were no non-conformances noted that could have contributed to this issue.

• Brand Name: PRODIGY IPG
• 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19057118
• Report Number: 1627487-2024-07978
• Device Sequence Number: 5859776
• Product Code: LGW
• UDI-Device Identifier: 05414734405485
• UDI-Public: (01)05414734405485(10)4950673(17)170128
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• 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
• Report Date (Section B): 07/24/2024

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: 01/28/2017
• Device Model Number: 3799
• Device Lot Number: 4950673
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 04/07/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2015
• 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: Unknown