MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 88C LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3289

Device Problems Disconnection (1171); Material Frayed (1262); Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

Event Date 02/06/2018

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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 1 of 3.Reference mfr.Report: 1627487-2018-02583.Reference mfr.Report: 1627487-2018-02584.It was reported the patient experienced ineffective stimulation due to a lead migration.Diagnostics revealed impedance issues, and x-rays revealed no lead is connected to the extension.As a result, the patient may be awaiting surgical intervention.

Event Description

Device 1 of 3, reference mfr.Report: 1627487-2018-02583; reference mfr.Report: 1627487-2018-02584.Follow up information identified the patient¿s lead was frayed and disconnected from the extension.The physician explanted the lead and one extension, and cut the second extension and partially explanted it on (b)(6) 2018.One new lead was implanted and no new extensions were implanted.The physician also relocated the ipg to the left lower back, and the lead was connected directly to the ipg.Postoperatively, effective therapy was restored.

• Brand Name: LAMITRODE 88C 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: 7341114
• MDR Text Key: 102465690
• Report Number: 1627487-2018-02582
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2009
• Device Model Number: 3289
• Device Lot Number: 65781
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2007
• 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 3662, SCS IPG
• Patient Outcome(s): Other
• Patient Age: 55 YR