BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2181473 · Received July 5, 2011

    Report

    Report Number
    3004209178-2011-05069
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING (B)(6) THE PT FELL AND HIT THE RIGHT SIDE OF THE HEAD, AFTER WHICH THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT THAT SAME DAY. IMPEDANCE READINGS ON THE RIGHT SIDE INS WERE >2000 OHMS ON SOME OF THE UNIPOLAR PAIRS. PREVIOUS READINGS TAKEN IN LATE MAY WERE WITHIN NORMAL RANGE. IMPEDANCE READINGS TAKEN ON THE LEFT SIDE INS WERE WITHIN NORMAL RANGE. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT WHEN ADDITIONAL INFO BECOMES AVAILABLE. SEE MFR REPORT #3004209178-2011-05070 REGARDING THE PT'S OTHER DEEP BRAIN STIMULATION SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU007143V| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LOT# NFW148029H| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU105055V| LEAD: MODEL 3387, LOT# J0230919V| EXPLANTED:| LEAD: MODEL 3387, LOT# J0231061V| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL005966P