BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 2100327 · Received May 13, 2011

    Report

    Report Number
    3004209178-2011-03491
    Event Type
    Malfunction
    Date Received
    May 13, 2011
    Date of Event
    January 1, 2010
    Report Date
    April 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN STIMULATION WAS ON, THE PATIENT FELT A "FLUTTER" UNDER THE LEFT BREAST, SHOCKING, AND PAIN OR DISCOMFORT, AND THAT THE PATIENT'S PULSE "JUMPED AT NIGHT." THE HEALTH CARE PROVIDER ATTRIBUTED THIS EVENT TO THE LEVEL AND LOCATION OF THE LEAD AND PLANNED TO REPROGRAM THE STIMULATOR USING LOWER ELECTRODES. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED CARDIAC PROBLEMS AND SHUT OFF THE INS WHILE ADDRESSING HER CARDIAC ISSUES, AND THAT FOLLOWING A POSITION CHANGE WHILE THE STIMULATION WAS TURNED ON THE PATIENT EXPERIENCED AN OVERSTIMULATION SENSATION AND STIMULATION IN THE CHEST. THERE WERE ALSO COUPLING OR COMMUNICATION ISSUES, AND AN OVERDISCHARGE DUE TO PATIENT COMPLIANCE WAS SUSPECTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED RECHARGEABLE LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37713 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR LEAD: MODEL 3778, LOT# V034964022| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD055145N| EXTENSION: MODEL 37081, LOT# NJB021650V| EXTENSION: MODEL 37081, LOT# NJB021698V| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V048563013| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA034092N| IMPLANTED: