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

Model Number 1192

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 08/23/2023

Event Type  Injury  

Manufacturer Narrative

Section b3: event date is estimated.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 323656787
• Report Number: 1627487-2023-04434
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/18/2023
• Supplement Dates Manufacturer Received: 09/28/2023
• Supplement Dates FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SCS LEAD (X1)
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 79 KG