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

Model Number 1192

Device Problems Break (1069); Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number:3006705815-2021-02360.It was reported that the patient experienced ineffective therapy.Troubleshooting revealed high impedances on one lead.As a result, surgical intervention was undertaken on (b)(6) 2021 wherein the lead and anchor were explanted and replaced.It was noted during the procedure that both the lead and anchor were broken.Effective therapy established post-op.

Manufacturer Narrative

The reported event of break was confirmed.Microscopic inspection of the return anchor revealed a broken proximal end.The cause of the break is consistent with an overstress condition or sudden event the lead may have been subjected to while in vivo.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: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11828900
• MDR Text Key: 250820519
• Report Number: 1627487-2021-14016
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 08/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6954388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS LEAD
• Patient Outcome(s): Other