BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHARGING SYSTEM

    MDR report key: 2970989 · Received February 15, 2013

    Report

    Report Number
    1627487-2013-01175
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-001-C
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CHARGER MODEL WAS ASSOCIATED WITH A FIELD CORRECTION. MANUFACTURER'S EVALUATION: CORRECTIVE AND PREVENTIVE ACTION (CAPA) INVESTIGATION WAS PERFORMED. EVALUATION CODES: RESULT: 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 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: 1627487-2013-1172. IT WAS REPORTED THE PATIENT'S IPG IS VERY CLOSE TO HER SKIN, AND IT CAUSES HER SOME DISCOMFORT. HER PHYSICIAN STATED THE PATIENT HAS A POCKET AREA NEAR THE IPG THAT IS CAUSING THE PAIN AND IT WILL TAKE SOME TIME TO COMPLETELY HEAL FROM THE PROCEDURE. THE PATIENT WAS TREATED WITH PAIN MEDICATION AND WILL FOLLOW-UP WITH HER PHYSICIAN IN (B)(6) 2013. IT WAS ALSO REPORTED THE PATIENT EXPERIENCED A HEATING SENSATION WHILE CHARGING HER IPG. THE HEATING ISSUE WAS RESOLVED BY REPLACING HER CHARGER WITH A NEW LE CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69501 CHARGING SYSTEM SCS CHARGER LGW ST. JUDE MEDICAL - NEUROMODULATION 3721 3797645

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention SCS LEAD: MODEL 3186 (2)| IMPLANT DATE: