BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5553722 · Received April 7, 2016

    Report

    Report Number
    3004209178-2016-06248
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    February 7, 2016
    Report Date
    May 6, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V047808, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V032332, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP). IT WAS REPORTED THAT TROUBLESHOOTING INCLUDED TURNING THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF. NO INFORMATION WAS PROVIDED REGARDING THE CAUSE OF THE REPORTED ISSUES.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THE PATIENT FELL ON (B)(6) 2016. THE PATIENT FELL AGAIN AND HIT THEIR HEAD ON (B)(6) 2016 AS A RESULT OF THEIR FIRST FALL. FOLLOWING THE FALL, THE PATIENT HAD A BUILDUP OF BLOOD ON THE BRAIN WHICH CAUSED SWELLING. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF SINCE THE PATIENT WAS HAVING SURGERY TO DRAIN FLUID FROM THEIR BRAIN BY THE LEADS. A TUBE WAS PLACED IN THE PATIENT'S HEAD TO DRAIN THE FLUID. DUE TO THE SWELLING, THE PATIENT WAS AFRAID THE LEADS MAY HAVE MOVED. ON (B)(6) 2016, STIMULATION WAS TURNED BACK ON AND THEY HAD A STRONG REACTION. THE PATIENT'S TREMORS WHEN AWAY, BUT THEIR SPEECH WAS SLURRED. STIMULATION WAS ONLY ON FOR A COUPLE OF MINUTES UNTIL THE INS WAS SHUT OFF. THE PATIENT'S INDICATION FOR USE IS ESSENTIAL TREMOR AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210510 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention