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

Model Number 1192

Device Problem Break (1069)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

Date of the event is estimated.

Event Description

Related manufacturer report 3006705815-2021-04308, related manufacturer report 3006705815-2021-04309, related manufacturer report 1627487-2021-16702.It was reported that lead migration issue was observed.Patient denies any traumas or falls.Patient did heavy lifting.Both leads were explanted, and the lead was replaced.During the explant procedure part of the anchor was broken and left in the patient.Patient was stable.

Manufacturer Narrative

The report event of lead migration cannot be confirmed with product testing alone.The anchors were returned complete (except b).Return anchors 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: 12409236
• MDR Text Key: 269772559
• Report Number: 1627487-2021-16703
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

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: 04/19/2023
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7918642
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCS ANCHOR; SCS LEAD X2
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 77