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

Model Number 2311

Device Problem Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

Manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 1 of 3 : reference mfr.Report# 1627487-2018-08741, reference mfr.Report# 1627487-2018-08742.It was reported during an ipg replacement procedure (1627487-2018-08747), system diagnostics revealed the competitors leads were not functioning due to impedance issue.As a result the procedure was aborted.Surgical intervention may occur later to address the issue.No products were implanted.

• Brand Name: 8-CHANNEL ADAPTER, MDT, 10CM
• Type of Device: SCS ADAPTER
• 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: falon whitfield ; 6901 preston road; plano, TX 75024 ; 9725268233
• MDR Report Key: 7882302
• MDR Text Key: 120453934
• Report Number: 1627487-2018-08740
• 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
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2019
• Device Model Number: 2311
• Device Lot Number: 6199318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2017
• 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