BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 1930330 · Received November 24, 2010

    Report

    Report Number
    3004209178-2010-09932
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    January 1, 2010
    Report Date
    November 23, 2010
    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
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS FOR THE PATIENT PROGRAMMER REVEALED A RELIABILITY NON-CONFORMANCE. RESOLDERED PIN 2 OF THE ANTENNA JACK AND A NEW BOTTOM HOUSING.

    Description of Event or Problem · 1

    REFERENCE MANUFACTURER # 3004209178201002698. THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENT BOTH WITH OR WITHOUT ANTENNA ATTACHED FOR THE PAST WEEK. SHE WAS ABLE TO ADJUST STIMULATION OCCASIONALLY. THE PATIENT PROGRAMMER WOULD NOT DO TELEMETRY WITH THE INTERNAL ANTENNA. PATIENT EXPERIENCED A SHOCKING SENSATION WHEN STIMULATION WAS ON OR OFF, STARTING 6 MONTHS AFTER IMPLANT. MOST OF THE INCIDENTS OCCURRED WHEN SHE WAS LAYING ON THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37701 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR IMPLANTED:| LEAD: MODEL 3777, LOT# V335425030| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE135961N| LEAD: MODEL 3777, LOT# V336264001| IMPLANTED:| EXPLANTED: