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

Model Number 3386

Device Problems Fracture (1260); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This report is related to a (b)(6) patient.It was reported the patient lost effective therapy due to high impedance.As a result, the patient's physician decided to explant their extension to address the issue.

Manufacturer Narrative

Brand name, model number, and pma/510(k) # were further confirmed following the return of the device.

Manufacturer Narrative

The report event of high impedance was confirmed.Analysis of the returned lead extension found all internal wires broken and detached in the header.The fracture observed would be consistent with an overstress condition or sudden event that the extension was subjected to while still in vivo.

• Brand Name: EXTENSION, 60CM
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 9275981
• MDR Text Key: 165197779
• Report Number: 1627487-2019-12351
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K000852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2019

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 Model Number: 3386
• Device Catalogue Number: 3386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 11/07/2019; 11/26/2019
• Supplement Dates FDA Received: 11/22/2019; 12/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other