MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16 LEAD, 60 CM; SCS LEAD

Model Number 3219

Device Problems Kinked (1339); Migration or Expulsion of Device (1395); Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/23/2015

Event Type  Injury  

Event Description

It was reported the patient could no longer feel stimulation.An impedance check revealed invalid impedances on multiple contacts.X-rays showed the lead tails were twisted and kinked from the ipg site up to the lead site and the lead had migrated.Reprogramming was attempted but could not provide resolution to the issue.As a result, the patient will undergo surgical intervention.

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 #: 1627487-2015-07213.Follow-up revealed the patient underwent surgical intervention.During the surgery, it was found the patient's ipg had flipped multiples times which coiled the lead and caused a lead fracture.As a result, the doctor decided to explant and replace the lead and the ipg with a different model.Effective therapy was obtained after the surgery.

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: LAMITRODE TRIPOLE 16 LEAD, 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: 4605652
• MDR Text Key: 5629647
• Report Number: 1627487-2015-07120
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2015
• Device Model Number: 3219
• Device Lot Number: 3905114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2013
• 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: MODEL: 3788, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 45 YR