BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2183695 · Received July 8, 2011

    Report

    Report Number
    3004209178-2011-05256
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Report Date
    June 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALY. THE IMPLANTED NEUROSTIMULATOR WAS RECEIVED WITH NO OUTPUT OR TELEMETRY FROM ANY ELECTRODE PAIR. THE DEVICE HAD BEEN IMPLANTED FOR 77.3 MONTHS; HOWEVER, PARAMETER HISTORY WAS NOT PROVIDED, THEREFORE A LONGEVITY CALCULATION COULD NOT BE COMPLETED. IT WAS ASSUMED THE DEVICE HAD REACHED A NORMAL END-OF-LIFE STATUS. VISUAL OBSERVATION REVEALED ALL FOUR SETSCREW GROMMETS HAVE A PUNCHOUT HOLE. ANALYSIS OF EXTENSION (LOT/SERIAL # (B)(4)) FOUND ALL FOUR CONDUCTORS WERE BROKEN AT THE EDGE OF THE MOLDED RUBBER AT THE PROXIMAL END. VISUAL OBSERVATION FOUND WHAT APPEARED TO BE PITTING ON THE #2 CONDUCTOR. THE DISTAL END OF THE EXTENSION WAS NOT RETURNED, NOR WAS THE LEAD BODY/INSULATION. THE INSULATION WAS BROKEN AT THE EDGE OF THE MOLDED RUBBER ON THE PROXIMAL END.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MFR WITH NO INFO. IT IS UNK IF AN EVENT OR PROBLEM OCCURRED THAT MAY HAVE LED TO EXPLANT. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU062508V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU076826V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0444192V| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU062508V| IMPLANTED:| LEAD: MODEL 3387, LOT# J0454516V