MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 30CM; SCS EXTENSION

Model Number 3343

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

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/21/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Device 3 of 3.Reference mfr.Report#: 1627487-2019-12285; reference mfr.Report#: 1627487-2019-12286.This report is related to a france patient.It was reported the patient lost therapy.An impedance check revealed high impedance.As a result, the patient plans to undergo surgical intervention on a later date to address the issue.

Manufacturer Narrative

Additional device information has been provided.

Event Description

Device 3 of 3.Reference mfr.Report#: 1627487-2019-12285.Reference mfr.Report#: 1627487-2019-12286.Follow-up revealed the patient's leads were explanted and replaced (with two different models) and their extension was explanted.Surgical intervention addressed the patient's issue.

Manufacturer Narrative

The reported high impedance was confirmed.The extension was returned cut, incomplete and with an electrode lodged in the connector block of port 1-4.These anomalies are consistent with explant damage.Microscopic inspection showed all the internal wires were broken in the strain relief.This catastrophic fracture would have contributed to the reported loss of therapy.As there was no instrumentation damage to the header or strain relief, and the ineffective therapy started prior to the revision, the broken wires are consistent with the extension being subjected to an overstress condition or sudden event while in vivo.

Event Description

Device 3 of 3.Reference mfr.Report#: 1627487-2019-12285, reference mfr.Report#: 1627487-2019-12286.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 30CM
• 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: 9269741
• MDR Text Key: 164722599
• Report Number: 1627487-2019-12287
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K960728
• 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: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2014
• Device Model Number: 3343
• Device Lot Number: 3640089
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2012
• 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
• Treatment: MODEL 3240, SCS LEAD; MODEL: 3240, SCS LEAD
• Patient Outcome(s): Other