BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1884634 · Received October 19, 2010

    Report

    Report Number
    3004209178-2010-08090
    Event Type
    Injury
    Date Received
    October 19, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 27, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THAT THE PT WAS UNABLE TO WALK AND HAD "MUSCLE SPASMS ALL OVER HIS BODY." THE SYMPTOMS OCCURRED AFTER THE PT WAS HOSPITALIZED TO HAVE HIS "ESOPHAGUS STRETCHED." THE PT WAS SEDATED FOR THE PROCEDURE. THE PT'S STATUS WAS REPORTED AS "FAIR." ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. SEE MFR REPORT #3004209178-2010-08094 REGARDING SECOND STIMULATOR.

    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 76 YR Other IMPLANTED:| LEAD: MODEL 3387, LOT# J0348754V| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0085738N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU030557V| IMPLANTED:| MODEL 7426, LOT# NFW159948H| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389, LOT# J0101900V