BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6209406 · Received December 28, 2016

    Report

    Report Number
    3004209178-2016-27299
    Event Type
    Injury
    Date Received
    December 28, 2016
    Report Date
    December 28, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994934611
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW OF THE FILE DETERMINED THAT (B)(4) WOULD ALSO APPLY TO CAPTURE THE STATEMENT THAT THE INS BECAME INVERTED AFTER THE FALL. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION DEVICE USED FOR WAS EZW-P970004.

    Description of Event or Problem · 1

    THE FAMILY OF A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION, FECAL INCONTINENCE, AND GASTROINTESTINAL/PELVIC FLOOR REPORTED THE PATIENT HAD A FALL (NO ALLEGATION THAT IT WAS CAUSED BE DEVICE OR THERAPY) AND THAT THE FALL CAUSED THE PATIENT'S INS TO BECOME INVERTED. THE INS WAS EXPLANTED, NO PATIENT SYMPTOMS WERE REPORTED. PATIENT STATUS IS UNKNOWN AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858758 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612 00613994934611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other