BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2094005 · Received May 13, 2011

    Report

    Report Number
    3004209178-2011-03497
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    February 14, 2011
    Report Date
    April 26, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT STARTED TO HAVE MORE MUSCLE CRAMPS WHICH CAUSED HER PAIN AND DISCOMFORT AT HER AFFECTED EXTREMITY. THE DEVICE WAS THEN TURNED OFF. THE PT DESIRED TO HAVE RECONSTRUCTIVE SURGERY ON HER LEFT ELBOW TO IMPROVE CONTRACTION AND PREVENT INJURY. THE NEUROSTIMULATOR REMOVED AS IT DID NOT IMPROVE HER SYMPTOMS AND DUE TO THE POSSIBILITY THAT SHE MADE NEED AN MRI. F/U INFORMATION REPORTED THAT THE PT DID HAVE SURGERY ON (B)(6) 2011 FOR A FUSION ON HER LEFT SHOULDER AND WAS DUE TO HAVE ADDITIONAL SURGERY (SCHEDULE (B)(6) 2011) TO HAVE HER LEFT ARM AMPUTATED ABOVE THE ELBOW. SHE WAS THEN GOING TO BE FITTED FOR A PROSTHESIS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A F/U REPORT WILL BE SENT.

    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 71 YR Required Intervention EXTENSION: MODEL 7482A51, LOT# NHU193050V| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V230720