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

Model Number 1192

Device Problem Fracture (1260)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 08/19/2022

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 3006705815-2022-16678; related manufacturer reference number: 3006705815-2022-16679; related manufacturer reference number: 1627487-2022-04965.It was reported that the patient¿s lead migrated.As such, surgical intervention took place on (b)(6) 2022.During the surgery it was noted that the anchors were broken.Per the physician, the patient is very thin and the leads were pretty superficial and the spinous process was protruding right near the anchors.As such, the bone was what broke the anchors.The leads and anchors were explanted and replaced to address the issue.Reportedly, therapy was resumed post operatively.

Event Description

Additional information received indicates that the patient experienced ineffective therapy due to the lead migration.

Manufacturer Narrative

The complaint was confirmed during the full system replacement swift lock anchors were found damaged.As received visual inspection anchor a was found cracked near the locking mechanism beyond functional test.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15384799
• MDR Text Key: 299552457
• Report Number: 1627487-2022-04964
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2019
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6132413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 09/08/2022; 10/27/2022
• Supplement Dates FDA Received: 09/16/2022; 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2017
• 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
• Treatment: SCS IPG
• Patient Outcome(s): Other
• Patient Sex: Female