MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B; DBS EXTENSION

Model Number 6372

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2020

Event Type  Injury  

Manufacturer Narrative

The results/ method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that a procedure the physician was unable to fully insert the existing original extension into the header of a new ipg.Multiple troubleshooting attempts were performed but were unsuccessful.As a result, the extension was explanted and replaced.The replacement extension resolved the issue.Therapy has been restored.

Manufacturer Narrative

The extension was returned with the nitinol sleeve broken in several places preventing it from being inserted into a lab ipg.There were drag marks and abrasions on the electrodes and spacers consistent with the terminal extension encountering resistance while being inserted inside the ipgs header during the procedure.As the extension had been successfully inserted and secured inside the previous ipg, the root cause of the insertion issue is a consequence of overstress the extension was subjected to during the procedure.

• Brand Name: 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B
• Type of Device: DBS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10336379
• MDR Text Key: 200760142
• Report Number: 1627487-2020-23232
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 05415067020857
• UDI-Public: 05415067020857
• Combination Product (y/n): N
• PMA/PMN Number: P140009
• 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: 11/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2019
• Device Model Number: 6372
• Device Catalogue Number: 6372
• Device Lot Number: 6016972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 59