MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION QUATTRODE LEAD, 3/6MM, 60 CM; SCS LEAD

Model Number 3156

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 01/26/2015

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr.Report# 1627487-2015-20163.It was reported the patient experienced unintended stimulation.A sjm representative tried reprogramming to no avail.X-rays revealed lead migration.Surgical intervention will be taken at a later date to address the issue.

Manufacturer Narrative

(b)(4).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.

Event Description

Device 1 of 2.Reference mfr.Report# 1627487-2015-20163.Additional information received identified the patient underwent surgical intervention on (b)(6) 2016 for lead revision.During the surgery the physician tried to reposition the leads to cover abdominal pain, however was unable to provide ideal coverage without having unintended stimulation.The physician tried troubleshooting to no avail and finished the procedure by positioning the leads where the patient could get the best coverage.The patient was receiving unintended leg stimulation too.Reportedly, the patient had coverage postoperatively.

• Brand Name: QUATTRODE LEAD, 3/6MM, 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
• MDR Report Key: 4606496
• MDR Text Key: 5699166
• Report Number: 1627487-2015-20162
• Device Sequence Number: 1
• Product Code: GZB
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 3156
• Device Lot Number: 4606870
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODEL 1192 (2), SCS ANCHOR; MODEL 3688, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 62 YR