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

Model Number 3383

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/10/2020

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

Related manufacturer reference numbers: 1627487-2020-31960, 1627487-2020-31961, 1627487-2020-31962. It was reported that the patient experienced ineffective stimulation since implant. Reprogramming was attempted, but did not restore effective stimulation. In turn, surgical intervention was undertaken on (b)(6) 2016, wherein the entire scs system was explanted. Post-operatively, it was discovered the paddle lead had pulled out. It is unknown if the lead pulled out from the extensions or the ipg, therefore all devices are being reported.

• Brand Name: EXTENSION, 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: 10599915
• MDR Text Key: 208957934
• Report Number: 1627487-2020-31963
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 09/29/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 06/28/2015
• Device MODEL Number: 3383
• Device Catalogue Number: 3383
• Device LOT Number: 4110721
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/17/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 06/10/2013
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data

Patient TREATMENT DATA

Date Received: 09/29/2020 Patient Sequence Number: 1

Treatment

SCS EXTENSION; SCS IPG; SCS PADDLE LEAD