BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 4252649 · Received November 5, 2014

    Report

    Report Number
    1627487-2014-12746
    Event Type
    Injury
    Date Received
    November 5, 2014
    Date of Event
    July 9, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF BATTERY DEPLETION WAS NOT CONFIRMED. THE IPG WAS RECEIVED IN GOOD CONDITION AND COMMUNICATED WITH LAB EQUIPMENT. THE LAB PT PROGRAMMER INITIALLY DISPLAYED THE LOW BATTERY WARNING PRIOR TO DECONTAMINATION; HOWEVER, THE LOW BATTERY WARNING WAS NOT OBSERVED AT THE TIME OF ANALYSIS. A PULSE LOAD TEST REVEALED THE LOADED BATTERY VOLTAGE REMAINED ABOVE THE LOW BATTERY THRESHOLD. BATTERY PASSIVATION COULD EXPLAIN THE LOW BATTERY FLAG OBSERVED IN THE FIELD AND PRIOR TO ANALYSIS. PRE-DECONTAMINATION COMMUNICATION WITH LAB UTILITIES AND LAB PT PROGRAMMER COULD CLEAR MINIMAL PASSIVATION. SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S IPG HAS THE LOW BATTERY WARNING. THE IPG WAS EXPLANTED AND REPLACED. THE PT'S STIMULATION WAS RESTORED FOLLOWING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710180 EONC SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3688 3790459

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other IMPLANT DATE:| SCS LEADS: MODEL 3186(2)