BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2153453 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-04632
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 24, 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
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A RETURN OF HER SYMPTOMS INCLUDING PAIN IN HER LEGS AND A RETURN OF HER TREMOR ON HER RIGHT SIDE. THE IMPLANTABLE NEUROSTIMULATOR (INS) ON HER LEFT SIDE WAS TURNING OFF INTERMITTENTLY. THE RIGHT SIDE INS WAS FINE. THE PATIENT SUSPECTED INTERFERENCE FROM HER REFRIGERATOR WAS CAUSING THE INS TO TURN OFF. THE PATIENT ALSO EXPERIENCED A SHOCKING OR JOLTING SENSATION WHEN SHE TURNED THE LEFT SIDE INS BACK ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 EXTENSION: MODEL 7482, LOT# NHU027034V| EXPLANTED:| LEAD: MODEL 3389, LOT# J0340529V| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU025911V| LEAD: MODEL 3389, LOT# J0340529V| EXPLANTED:| EXPLANTED:| IMPLANTED:| LOT# NFW169697H