MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SCS LEAD ANCHOR

Model Number	1192
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Implant Pain (4561)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: event date is estimated.
Event or Problem Description
Related manufacturer report number: 3006705815-2023-05810.It was reported that the patient was experiencing irritation at the site of the scs lead anchor.Surgical intervention was undertaken on (b)(6) 2023 wherein the patient's scs lead anchor was buried deeper and flatter to address the issue.Additionally, during the mentioned revision the physician noted a spark and a loss of wireless connection to the ipg while cauterization was taking place.Troubleshooting was attempted during the procedure and the ipg was successfully reconnected.Therapy was restored post operatively.
Additional Manufacturer Narrative
The event of a scheduled revision was reported to abbott.Imaging was done at the patient¿s trailing physician's office and did not show any issues despite the rep having issues with impedance.The surgery was just intended to bury the patients anchors deeper and flatter to decrease irritation.The patient¿s therapy was working well prior to surgery.There was a complication with the ipg.Although the device had been placed in surgery mode, a spark was seen when the physician when using cautery.The ipg lost communication but was able to be recovered.Nothing was explanted.Effective therapy was restored.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, the cause of the reported issue was determined not to be product related.

• Brand Name: SWIFT-LOCK ANCHOR
• Common Device Name: SCS LEAD ANCHOR
• 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: 17768865
• Report Number: 1627487-2023-04434
• Device Sequence Number: 12561081
• Product Code: GZB
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K092371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 10/05/2023

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: 07/01/2023
• Device Model Number: 1192
• Device Lot Number: 8028387
• 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: 08/23/2023
• Supplement Date Received by Manufacturer: 09/28/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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 LEAD (X1)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 79 KG