BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2093993 · Received May 13, 2011

    Report

    Report Number
    3004209178-2011-03487
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 18, 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 REPORTED THERE WERE HIGH IMPEDANCES. SOME OF THE BIPOLAR PAIRS HAD IMPEDANCE READINGS >4000 OHMS. THE EXTENSION AND BATTERY WERE REPLACED. THE BATTERY WAS REPLACED BECAUSE IT WAS (B)(4), AND THE PT DID NOT WANT TO HAVE AN ADDITIONAL SURGERY TO REPLACE IT WHEN THE BATTERY DIED. THE LEAD WAS NOT REPLACED BECAUSE IT TESTED "FINE." THE PT HAD "GOOD" STIMULATION FOLLOWING THE REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention PROGRAMMER: MODEL 37742, LOT# NJD049097N| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC014984N| IMPLANTED:| LEAD: MODEL 3986A, LOT# N066617| EXPLANTED:| IMPLANTED: