MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD WIDE SPACED, 90 CM; PNS LEAD

Model Number 3169

Device Problems Fracture (1260); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/28/2018

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 3 of 4.Reference mfr.Report# 1627487-2018-09501.Reference mfr.Report# 1627487-2018-09502.Reference mfr.Report# 1627487-2018-09504.It was reported the patient experienced inadequate stimulation.System diagnostics revealed high impedances on the right occipital lead.In turn, imaging revealed a fracture in the right occipital lead and a kink in the left occipital lead.Reprogramming was tried to no avail.As a result, the patient underwent surgical intervention wherein both leads were explanted and replaced.It is unknown which lead is related to the issue.Therefore, all the suspected devices are being reported.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 90 CM
• Type of Device: PNS LEAD
• 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: 7931405
• MDR Text Key: 122540437
• Report Number: 1627487-2018-09503
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 05414734406116
• UDI-Public: 05414734406116
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2019
• Device Model Number: 3169
• Device Catalogue Number: 3169
• Device Lot Number: 5912211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2017
• 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
• Treatment: MODEL 1192 (2), SCS ANCHORS; MODEL 3341 (2), SCS EXTENSIONS; MODEL 3772, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 43 YR