MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3286

Device Problem High impedance (1291)

Patient Problems Device Overstimulation of Tissue (1991); Burning Sensation (2146); Inadequate Pain Relief (2388)

Event Date 04/20/2017

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

Event Description

Device #2 of 2: reference mfr.Report: 1627487-2018-00007.This patient is implanted with two cervical leads and the manufacturer is unable to determine which lead is liable thus both are reported.It was reported the patient was experiencing painful stimulation.The patient is experiencing a burning sensation in her leg when she moves her neck to the left.The sensation is diminished when therapy is turned off.In addition, the patient is no longer receiving effective stimulation.These issues began approximately six months ago.The patient has turned the scs system off.X-ray showed no anomalies.Lead diagnostics showed multiple high impedances.Reprogramming did not resolve the issue.Surgical intervention may be pending to address this issue.

Event Description

Device #2 of 2: reference mfr.Report: 1627487-2018-00007.Follow up information identified the patient underwent surgical intervention on (b)(6) 2018 where the leads were removed and replaced.Postoperatively, the patient is receiving effective stimulation.

• Brand Name: LAMITRODE S-8 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: 7158847
• MDR Text Key: 96206015
• Report Number: 1627487-2018-00006
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2007
• Device Model Number: 3286
• Device Lot Number: 47649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: 05/29/2018
• Supplement Dates FDA Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2005
• 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
• Patient Outcome(s): Other
• Patient Age: 59 YR