BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1900482 · Received October 28, 2010

    Report

    Report Number
    3004209178-2010-08595
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 3, 2010
    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
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION FROM THEIR DEVICE "UP THE LEFT SIDE OF HER FACE." THE PT WAS REFERRED TO THEIR HEALTHCARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE MFR. REPORT # 3004209178201008596.

    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 86 YR EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU066647V| EXPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438 , LOT# NHL012468P| LEAD: MODEL 3387, LOT# J0443962V| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0443962V| EXPLANTED:| IMPLANTED:| LOT# NFW148879H| EXTENSION: MODEL 7482, LOT# NHU069871V