MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION SWIFT-LOCK ANCHOR; SCS ANCHOR

Model Number 1192

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/04/2020

Event Type  Injury  

Manufacturer Narrative

Date of the event is estimated.During processing of this complaint, attempts were made to obtain complete event information.The results/ method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Device 5 of 5.Related manufacturer reference number: 3006705815-2020-31568, related manufacturer reference number: 3006705815-2020-31569, related manufacturer reference number: 3006705815-2020-31570, related manufacturer reference number: 1627487-2020-31761.It was reported the patient experienced pain at the midline incision site, as well as at the ipg site.The physician thinks the lead may be too close to the surface of the skin.To address the issue, the patient may be awaiting surgical intervention.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

Event Description

Additional information found the patient underwent an ipg and anchor revision on (b)(6)2020 to resolve the issue.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SCS ANCHOR
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10567521
• MDR Text Key: 207948942
• Report Number: 1627487-2020-31762
• 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,Followup
• Report Date: 12/10/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2021
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7295677
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/22/2020
• Supplement Dates Manufacturer Received: 11/10/2020; 12/06/2020
• Supplement Dates FDA Received: 12/03/2020; 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 1192; MODEL 3186 (X2); MODEL 3660; MODEL 1192; MODEL 3186 (X2); MODEL 3660
• Patient Outcome(s): Other