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

Model Number 3341

Device Problems Disconnection (1171); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/03/2018

Event Type  Injury  

Event Description

Device 3 of 3: reference mfr report#3006705815-2018-03459, reference mfr report#1627487-2018-13404.It was reported that the lead diagnostics revealed high impedances on the contacts.X rays confirmed extension was pulled from the header of the ipg.As a result, surgical intervention was undertaken on (b)(6) 2018, wherein the extensions were replaced electively because the lead was disconnected and fluid invasion was a concern.Reportedly, stimulation was restored post-operatively.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 10CM
• 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: 8201010
• MDR Text Key: 131580097
• Report Number: 1627487-2018-13405
• 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: K930536
• 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: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2020
• Device Model Number: 3341
• Device Lot Number: 6409985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2018
• 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: 31 YR