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

Model Number 1192

Device Problem Fracture (1260)

Patient Problems Undesired Nerve Stimulation (1980); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

¿date of event¿ is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference numbers: 3006705815-2020-32703, 3006705815-2020-32704, 1627487-2020-49023, 1627487-2020-49026.It was reported that patient fell and experienced uncomfortable therapy in the wrong location.Diagnostics showed low impedance on multiple contacts of the leads.Additional information was received that patient also experienced shocking in ipg pocket.Surgery occurred to address the issue.During the surgery, one anchor and one lead were found to be broken.The system was replaced to address the issue.It is unknown which anchor and lead were broken so all suspected devices are being reported.

Manufacturer Narrative

The reported uncomfortable stimulation and impedance issues were not confirmed.The anchor was returned with part of the distal sleeve trimmed off.It could not be determined if this was a modification.When tested with lab lead, it functioned as intended.The root cause of the reported issue could not be conclusively determined.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11061619
• MDR Text Key: 223371150
• Report Number: 1627487-2020-49025
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2019
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 6142450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD (X2); SCS ANCHOR; SCS IPG; PERCUTANEOUS LEAD (X2); SCS ANCHOR; SCS IPG
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 118