MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE; SCS LEAD

Model Number 3166

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 09/29/2014

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr report#: 1627487-2014-08381 and 08382.The patient is implanted with two model 3166 leads from lot 3952860.It was reported the patient is experiencing overstimulation from his pns (off-label) system.An sjm representative advised the patient to turn his system off.Surgical intervention is planned for a later date to address the issue.

Manufacturer Narrative

Sjm 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.Sjm defers to the patient's physician regarding medical history.

• Brand Name: QUATTRODE
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: logan farmer ; 6901 preston rd.; plano, TX 75024 ; 9725269611
• MDR Report Key: 4240269
• MDR Text Key: 4990559
• Report Number: 1627487-2014-08373
• Device Sequence Number: 1
• Product Code: GZF
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 10/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Model Number: 3166
• Device Lot Number: 3952860
• Other Device ID Number: 05414734401661
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• 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 EXTENSION: MODEL 3341 (X2); IMPLANT:; SCS IPG: MODEL 3788; IMPLANT:
• Patient Outcome(s): Other
• Patient Age: 42 YR