BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4240479 · Received October 30, 2014

    Report

    Report Number
    1627487-2014-26919
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 10, 2014
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    DEVICE #2 OF 2: REFERENCE MFR. REPORT: 1627487-2014-26918. IT WAS REPORTED THE IPG WAS UNABLE TO COMMUNICATE WITH CHARGER FOR THE PAST MONTH. IN ADDITION, THE PATIENT REPORTS SHE EXPERIENCED POCKET HEATING WHILE RECHARGING FOR THE PAST 7-8 MONTHS AS WELL AS THE CHARGER PADDLE BECOMING WARM. THE PATIENT REPORTS SHE WOULD TAKE A BREAK FROM CHARGING ONCE THE HEATING BECAME UNCOMFORTABLE. A REPLACEMENT MODEL 3726 CHARGING SYSTEM WAS SENT TO THE PATIENT WHICH RESOLVED THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696982 PENTA SCS LEAD GZB ST. JUDE MED - NEUROMODULATION 3228 3761691

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other SCS ANCHOR: MODEL 1194(2)| IMPLANT DATE: