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 06/08/2020

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive as the product was not returned for analysis.

Event Description

Related mfr reports: 3006705815-2020-31907, 3006705815-2020-31908 and 1627487-2020-32430.It was reported the patient complained of pain and went to the er where she was diagnosed with a bulging disk.X-rays showed the scs system lead anchor might had broken and the lead shifted one vertebral body down.Reportedly, the patient stated she lifted a 50lb bag of dirt prior to the event.A system diagnostic showed high impedance for one of the leads.Surgical intervention was taken, the lead suspected of having the anchor break was revised and the reported issue addressed.

Event Description

Related mfr reports: 3006705815-2020-31907, 3006705815-2020-31908 and 1627487-2020-32430.

Manufacturer Narrative

The event information pertaining to this incident has been reviewed and no product investigation can be performed as there are no complaint allegations present nor were the circumstances of the event attributed to a malfunction of the implanted system.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10659198
• MDR Text Key: 210713866
• Report Number: 1627487-2020-32429
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734400671
• UDI-Public: 05414734400671
• 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: 11/17/2020

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: 01/18/2021
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6803445
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 1192, SCS ANCHOR.; MODEL 3186 (X2), SCS LEAD.; MODEL 1192, SCS ANCHOR; MODEL 3186 (X2), SCS LEAD
• Patient Outcome(s): Other
• Patient Weight: 84