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

Model Number 3341

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/01/2016

Event Type  Injury  

Manufacturer Narrative

Event and therapy date is estimated.Explant date is unknown.Further information was requested but not available.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

Manufacturer report number: 3006705815-2020-01794, 1627487-2020-04443, 1627487-2020-04444, 1627487-2020-04446,1627487-2020-04448, 1627487-2020-04450 it was reported patient experienced ineffective therapy from (b)(6) 2016.To address this issue patient had her whole system explanted on an unknown date, but parts of the leads were left in patient.

• 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: 10034124
• MDR Text Key: 190184009
• Report Number: 1627487-2020-04447
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 3341
• Device Catalogue Number: 3341
• Device Lot Number: 4768937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/23/2020
• Initial Date FDA Received: 05/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2014
• 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 EXT; SCS IPG; SCS LEADS X 4
• Patient Outcome(s): Other