BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 2993959 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-10065
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CHARGER MODEL NUMBER WAS ASSOCIATED IN A FIELD CORRECTION. MFRS EVAL: CORRECTIVE AND PREVENTIVE ACTION (CAPA). RESULTS: POCKET HEATING WAS CONFIRMED. THE INVESTIGATION FOR (B)(4) ASSOCIATED WITH HEATING WHILE CHARGING (POCKET HEATING) CONCLUDED THAT THE CHARGER WAS CAPABLE OF TRANSFERRING ENERGY TO THE IPG AT A RATE THAT WOULD CAUSE HEATING OF THE IPG AND/OR CHARGING WAND OF SUFFICIENT ELEVATED TEMPERATURE TO CAUSE PAIN AND BURNS. THE HEATING WHILE CHARGING WAS DETERMINED TO BE EXACERBATED BY OFF-AXIS CHARGING OF SHALLOW IMPLANTED IPGS AND THAT ALL CHARGERS WERE CAPABLE OF ELEVATED HEATING. SJM HAS LIMITED INFO 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2013-10064. IT WAS REPORTED THE PATIENT ((B)(6)) EXPERIENCED DISCOMFORT WHILE CHARGING THE IPG. THE PATIENT REPORTED SHE DEVELOPED BRUISES AND LESIONS ON THE SKIN SURROUNDING THE IPG SITE. THE PHYSICIAN ELECTED TO EXPLANT AND REPLACE THE IPG UPON EXPLANT, THE PHYSICIAN NOTED THAT THE IPG POCKET WAS AFFECTED BY BURNS. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89271 CHARGING SYSTEM SCS CHARGING SYSTEM LGW ST. JUDE MEDICAL - NEUROMODULATION 3721 3301853

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention