MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 10CM; SCS LEAD ACCESSORY

Model Number 3341

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 1627487-2019-10791, 1627487-2019-10792, 1627487-2019-10793, 1627487-2019-10794, 1627487-2019-10795, 3006705815-2019-03646.It was reported the patient experienced uncomfortable stimulation with their scs system.Troubleshooting was unable to resolve the issue.As a result the patient underwent surgical intervention on (b)(6) 2019 wherein the entire scs system was explanted.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 10CM
• Type of Device: SCS LEAD ACCESSORY
• 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: 9113895
• MDR Text Key: 159922435
• Report Number: 1627487-2019-10796
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402279
• UDI-Public: 05414734402279
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/24/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2019
• Device Model Number: 3341
• Device Lot Number: 5984693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2017
• 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
• Patient Age: 36 YR
• Patient Weight: 64