BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMITRODE TRIPOLE 16

    MDR report key: 3010816 · Received March 14, 2013

    Report

    Report Number
    1627487-2013-02369
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 21, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT LOST STIMULATION AND WHEN SHE PRESSED THE "+" BUTTON ON HER PROGRAMMER SHE COULD NOT FEEL STIMULATION. A REPLACEMENT PROGRAMMER WAS UNABLE TO RESOLVE THE ISSUE. DIAGNOSTIC TESTING REVEALED INVALID IMPEDANCE READINGS ON MULTIPLE LEAD CONTACTS. REPROGRAMMING AROUND THE INVALID CONTACTS ALLEGEDLY WAS UNSUCCESSFUL. IT WAS REPORTED THE SJM REP WILL MEET WITH THE PT AGAIN AND SURGICAL INTERVENTION WILL MOST LIKELY BE UNDERTAKEN TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108357 AMITRODE TRIPOLE 16 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 3710171

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR SCS EXTENSION, MODEL 3382 (2)| IMPLANT DATE:| IMPLANT DATE:| SCS IPG, MODEL 3788