MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD WIDE SPACED, 60 CM; SCS LEAD

Model Number 3166

Device Problem High impedance (1291)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

The 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 1 of 4.Reference mfr.Report: 1627487-2018-08140.Reference mfr.Report: 1627487-2018-08141.Reference mfr.Report: 1627487-2018-08142.It was reported during programming after the patient suffered a fall, one of the patient¿s leads displayed high impedances.It was discovered 1 of 4 leads were not working.Reprogramming partially restored therapy.As a result, the patient is awaiting surgical intervention.

Event Description

Device 1 of 4; reference mfr.Report: 1627487-2018-08140, reference mfr.Report: 1627487-2018-08141, reference mfr.Report: 1627487-2018-08142.Follow-up information provided the patient had 4 leads explanted due to high impedances and replaced with 2 new leads.Effective stimulation was restored.

• Brand Name: QUATTRODE LEAD WIDE SPACED, 60 CM
• Type of Device: SCS 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: nirvana williams ; 9723098568
• MDR Report Key: 7828470
• MDR Text Key: 118618790
• Report Number: 1627487-2018-08139
• Device Sequence Number: 1
• Product Code: GZB
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2010
• Device Model Number: 3166
• Device Lot Number: 174766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2008
• 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 3341 (X2), SCS EXTENSION; MODEL 3716, SCS IPG
• Patient Outcome(s): Other