MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXT, REC 8CH 30CM; SCS EXTENSION

Model Number 3383

Device Problem High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

The report event of high impedance was confirmed.As received, the extension lead was complete.Analysis of the returned lead extension found all internal wires broken and detached in the header.Some of broken wires are pulled back inside strain relief.The fracture observed was consistent with an overstress condition or sudden event that the extension was subjected to while still in vivo.

Event Description

Device 3 of 3; reference mfr.Report: 1627487-2019-05045, reference mfr.Report: 1627487-2019-05046.It was reported the experienced high impedances on one contact during a programming session on (b)(6) 2019, but therapy was unaffected at the time.The patient later underwent an ipg replacement on (b)(6) 2019, and the patient¿s two octrode leads were connected to the new ipg.Diagnostics at that time revealed high impedances on all contacts.The physician then connected the existing leads to an external pulse generator (epg), and the high impedances remained, thus the physician concluded the leads were the cause of the impedance issue.The physician reconnected the leads to the new ipg, completing the implant procedure.Follow up information identified the physician opted to explant the scs system and replace it with a competitor¿s ipg and leads on (b)(6) 2019.It was also discovered the patient had one exclaim paddle lead and one octrode lead instead of the originally thought two octrode leads.Devices were later received for analysis along with a previously unreported 3383 extension.The extension has been added as a third reportable device.Device model numbers have been provided, but specific device information and implant dates are still unknown at this time.

• Brand Name: EXT, REC 8CH 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: 8746179
• MDR Text Key: 149624460
• Report Number: 1627487-2019-07556
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Report Date: 06/28/2019

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: 3383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 06/28/2019
• 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