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

Model Number 1192

Device Problem Fracture (1260)

Patient Problems Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference numbers: 3006705815-2021-00638, 3006705815-2021-00639, 1627487-2021-01300.It was reported that the patient experienced ineffective stimulation.Imaging revealed one of the leads had migrated.In turn, surgical intervention was undertaken wherein all leads and anchors were explanted and replaced.During the procedure, it was discovered that one of the anchors was broken.Post-operatively, stimulation therapy was restored.It is unknown which lead migrated and which anchor was broken, therefore all applicable devices are being reported.

Manufacturer Narrative

The report event of lead migration cannot be confirmed, with product testing alone.The anchor was returned complete.Return anchor passed functional test.No root cause was identified for reported event.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11326112
• MDR Text Key: 240170214
• Report Number: 1627487-2021-01301
• 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: 03/15/2021

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: 04/14/2021
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6945435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2021
• Initial Date FDA Received: 02/14/2021
• Supplement Dates Manufacturer Received: 03/08/2021
• Supplement Dates FDA Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD (X2); SCS ANCHOR
• Patient Outcome(s): Other
• Patient Weight: 95