MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3186

Device Problem Improper Device Output (2953)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/29/2015

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr.Report# 1627487-2015-20317.

Event Description

Device 1 of 2.Reference mfr.Report# 1627487-2015-20317.

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.

Manufacturer Narrative

Result : the reported issue of the system auto reducing was confirmed.The issue was attributed to broken wires in the lead body.Visual inspection of returned lead identified broken wires in the lead body.Continuity testing identified 4 channels electrically open.The broken wires would have created high impedance and could cause the system to auto reduce.The broken wires are consistent with an overstress condition the lead was subjected to at the distal end of the swift-lock while in vivo.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# 1627487-2015-20317.It was reported the patient experienced loss of stimulation as the scs system was autoreducing.System diagnostics revealed invalid impedances on the leads.Subsequently, the surgical intervention was taken to explant and replace the leads.

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.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• 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: 4801031
• MDR Text Key: 5843638
• Report Number: 1627487-2015-20316
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2016
• Device Model Number: 3186
• Device Lot Number: 4640022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/04/2014
• 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 ANCHOR; MODEL 3789, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 37 YR