MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 10CM; SCS EXTENSION

Model Number	3341
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event is estimated.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 incident could not be conclusively determined.
Event or Problem Description
Related manufacturer reference number: 1627487-2024-00406, 1627487-2024-00407, 1627487-2024-00408.It was reported that patient experienced ineffective therapy.Lead diagnostics showed that all the leads had high impedances.Surgical intervention was undertaken, and during procedure, it was noted one of the 3166 leads had pulled out of the extension causing concern about the integrity of the extension.In turn, the system the leads and extension were explanted and replaced.Effective therapy was restored.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 10CM
• Common Device Name: SCS EXTENSION
• 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: 18568155
• Report Number: 1627487-2024-00409
• Device Sequence Number: 15504773
• Product Code: LGW
• UDI-Device Identifier: 05414734402279
• UDI-Public: 05414734402279
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/23/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2014
• Device Model Number: 3341
• Device Lot Number: 3736393
• 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: 01/08/2024
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2012
• 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 IPG (1)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 86 KG