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 02/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer reference numbers: 1627487-2020-02630, 1627487-2020-02631, 1627487-2020-02632.It was reported that the patient experienced ineffective stimulation due to the leads disconnecting.In turn, surgical intervention was undertaken in 2012 (exact date unknown) wherein the entire scs system was explanted.It is not know which devices the disconnection occurred, therefore all devices are being reported.

Manufacturer Narrative

This device is no longer reportable.

Event Description

Additional information received stated that there was no issue with this device.The paddle lead had migrated.This device is no longer reportable.

• 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: 9818054
• MDR Text Key: 182953723
• Report Number: 1627487-2020-02633
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402323
• UDI-Public: 05414734402323
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2011
• Device Model Number: 3383
• Device Catalogue Number: 3383
• Device Lot Number: 2844844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/2009
• 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: SCS EXTENSION; SCS IPG; SCS PADDLE LEAD
• Patient Outcome(s): Other