MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 8-CHANNEL ADAPTER, MDT, 10CM; SCS EXTENSION

Model Number 2311

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

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/20/2018

Event Type  Injury  

Event Description

Device 4 of 4.Reference mfr.Report#: 1627487-2018-12982, reference mfr.Report#: 1627487-2018-12981, reference mfr.Report#:1627487-2018-12980.It was reported the patient experienced inadequate stimulation.As a result, surgical intervention may be planned to address this issue.

Event Description

Device 4 of 4: reference mfr.Report#: 1627487-2018-12982, reference mfr.Report#: 1627487-2018-12981, reference mfr.Report#:1627487-2018-12980.Additional information received identified the patient underwent surgical intervention wherein the scs system was explanted.

• Brand Name: 8-CHANNEL ADAPTER, MDT, 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: 8157075
• MDR Text Key: 130163072
• Report Number: 1627487-2018-12979
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067016119
• UDI-Public: 05415067016119
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 2311
• Device Catalogue Number: 2311
• Device Lot Number: 5999226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2017
• 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