BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 1885281 · Received October 25, 2010

    Report

    Report Number
    3004209178-2010-08427
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    May 1, 2010
    Report Date
    May 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
    SD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THE PT EXPERIENCED A RETURN OF TREMORS ON THE LEFT SIDE OF THEIR BODY. IT WAS STATED THE PT HAD AN APPOINTMENT WITH THEIR HEALTH CARE PROVIDER UPCOMING. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L INFO 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 74 YR IMPLANTED:| LEAD: MODEL 3387, LOT# J0220102V| EXTENSION: MODEL 7495LZ, LOT# NHK016111V| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT# NHL004484P| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED: