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

Model Number 3346

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Device Overstimulation of Tissue (1991); Pain (1994); Burning Sensation (2146)

Event Date 01/20/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Date of explant is estimated.During processing of this complaint, attempts were made to obtain complete event and patient information.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: 1627487-2020-01315, 1627487-2020-01316, 1627487-2020-01317, 1627487-2020-01318, 1627487-2020-01320.It was reported that patient scs system was explanted due to patient experiencing discomfort pain and burning sensation due to stimulation.That is all the information available at this time.

• 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
• 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: 9683643
• MDR Text Key: 178224285
• Report Number: 1627487-2020-01319
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402309
• UDI-Public: 05414734402309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2012
• Device Model Number: 3346
• Device Catalogue Number: 3346
• Device Lot Number: 3066206
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2010
• 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: LEAD EXTENSION; SCS LEAD (4)
• Patient Outcome(s): Other
• Patient Age: 28 YR