BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1980368 · Received February 3, 2011

    Report

    Report Number
    3004209178-2011-00861
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    September 1, 2010
    Report Date
    January 25, 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).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PT HAD A SUSPECTED OVERDISCHARGE CONDITION ON THEIR DEVICE. SHE WAS PREGNANT AND DID NOT CHARGE FOR 9 MONTHS. FOLLOW-UP INFO INDICATED THE PT WAS ABLE TO RECHARGE SUCCESSFULLY (VIA A TRICKLE CHARGE). IT WAS THEN REPORTED THAT SHE HAD A SEIZURE, FELL, AND FRACTURED HER LEADS. A LEAD REVISION WAS PERFORMED ON (B)(6) 2010. SUBSEQUENTLY, SHE WAS HAPPY WITH HER STIMULATION.

    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 29 YR Required Intervention IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V248220013| ACCESSORY: MODEL 37752, LOT# NKA122652N| LEAD: MODEL 3777, LOT # V166858033| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE126246N