BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2001545 · Received January 26, 2011

    Report

    Report Number
    3004209178-2011-00635
    Event Type
    Malfunction
    Date Received
    January 26, 2011
    Report Date
    January 13, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT COULD NOT SUCCESSFULLY RECHARGE; SHE HAD NOT RECHARGED SINCE APPROX 1.5 YEARS PRIOR TO (B)(6) 2010. THE RECHARGER BATTERY WAS DEAD. THE PT MET WITH HER PHYSICIAN AND THE DEVICE WAS REPROGRAMMED TWICE, ON (B)(6) 2010 AND (B)(6) 2010. IT WAS ALSO STATED THAT THE DEVICE HAD NOT BEEN WORKING PROPERLY PRIOR TO THE PT STOPPING CHARGING IN 2009. THERE HAD BEEN NO FURTHER COMPLAINTS FROM THE PT AND THE PLAN FOR HER WAS TO CONTINUE FOLLOW-UP WITH HER PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB047848V| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB047352V| EXPLANTED:| LEAD: MODEL 39565-30, LOT# N169554002| ACCESSORY: MODEL 37752, LOT# NKA122203N| PROGRAMMER: MODEL 37743, LOT# NKE119492N