BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED RECHARGEABLE

    MDR report key: 1983988 · Received February 7, 2011

    Report

    Report Number
    3004209178-2011-00927
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    RECEIVED INFO THE BATTERY WAS DEPLETED AFTER VERDISCHARGING TWO TIMES. THE BATTERY DEPLETED DUE TO INSUFFICIENT RECHARGING. THE BATTERY RECOVERED AFTER THE FIRST DEPLETION. HOWEVER, AFTER THE SECOND TIME RECOVERY WAS NOT POSSIBLE. THE RECHARGER WAS VERIFIED AS WORKING PROPERLY. THE PT HAD BEEN COMPLAINING ABOUT DIFFICULTIES IN RECHARGING WHICH MIGHT BE THE REASON FOR DEPLETION. AFTER REPLACEMENT TO A PRIME ADVANCE THE PT EXPERIENCED A SATISFYING STIMULATION. THE PT ALSO NOTED THE INS WAS ACTING STRANGELY BEFORE THE DEPLETION. PT EXPLAINS IT WAS IF THE INS WAS "RUSHING AND THUS DELIVERED AN UNEVEN STIMULATION." THE PT WAS SATISFIED WITH THE TREATMENT AT THE START, AND THE PROBLEMS BEGAN 6 TO 12 MONTHS AFTER IMPLANTATION. DUE TO PROBLEMS WITH THE INS THE PT WAS SUBJECTED TO MORE ANGINA PECTORIS ATTACKS. HOWEVER, WITH THE INS CHANGE THE PT IS EXPERIENCING A MORE POSITIVE CHANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL PLUG/IPG, LOT# UNK