MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 60CM; SCS EXTENSION

Model Number 3386

Device Problems Break (1069); High impedance (1291); Material Twisted/Bent (2981)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/06/2020

Event Type  Injury  

Manufacturer Narrative

During processing of this incident, attempts were made to obtain complete device information.Unique device identifier (udi #): the udi is unknown because the lot number was not provided.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient experienced loss of stimulation due to high impedance.As such, surgical intervention took place on (b)(6) 2020 during which the physician noted there was a kink on the extension.As such, the extension was explanted and replaced with a new extension to address the issue.Reportedly, therapy was established post operatively.

Manufacturer Narrative

The report of high impedance was confirmed.Visual inspection of the returned lead extension identified all the internal wires were broken in the lead body just below the strin relief.The broken wires are consistent with an overstress condition or sudden event (the report stated the patient fell) the lead extension was subjected to while in vivo.Corrected h6 device code.

• Brand Name: EXTENSION, 60CM
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10308758
• MDR Text Key: 199908070
• Report Number: 1627487-2020-23083
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: K000852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3386
• Device Catalogue Number: 3386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other