MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR

Model Number 1192

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 3006705815-2020-32792, 3006705815-2020-32793, and 1627487-2020-47925.It was reported that the patient¿s system began auto reducing to zero.Diagnostic testing indicated high impedance on the implanted lead.As a result, the patient¿s lead was replaced, during surgery it was noted that both leads and both anchors were fractured.New leads and anchors were implanted and the issue resolved on (b)(6) 2020.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 10880379
• MDR Text Key: 217649412
• Report Number: 1627487-2020-47926
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2019
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6192253
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2017
• 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
• Patient Outcome(s): Other
• Patient Weight: 82