MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 60CM; SCS EXTENSION

Model Number 3346

Device Problems Disconnection (1171); High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Device 2 of 3; related manufacturer reference number: 1627487-2020-23246, related manufacturer reference number: 1627487-2020-23248.It was reported the patient showed high impedances on two contacts, although stimulation was effective.X-rays revealed the patient¿s left quattrode was not fully inserted into the extension.To address the issue, the physician explanted and replaced the patient¿s extension on (b)(6) 2020.After changing the extension, one impedance on the right lead remained high, and the left side showed normal impedances.Postoperatively, effective stimulation was achieved.Note: it is unknown which quattrode serial number was affected, therefore both are being reported.

Manufacturer Narrative

As received, the dual lead extensions microscopic inspection showed multiple broken wires inside the strain relief.It was complete and had no anomaly.Return dual lead extensions passed continuity testing and output resistance measurement.The cause of the reported event is consistent with an overstress condition or sudden event the lead was subjected while in vivo.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 60CM
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10382740
• MDR Text Key: 202170938
• Report Number: 1627487-2020-23247
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402309
• UDI-Public: 05414734402309
• Combination Product (y/n): N
• PMA/PMN Number: K032751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2015
• Device Model Number: 3346
• Device Catalogue Number: 3346
• Device Lot Number: 4159590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3153 (X2)
• Patient Outcome(s): Other