BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2924686 · Received January 22, 2013

    Report

    Report Number
    3004209178-2013-00810
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    December 31, 2012
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 64001, LOT# N240190, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ADAPTER; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT# V000525, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT# V004841, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELL ON A FIVE GALLON BUCKET ABOUT 3 TO 4 WEEKS PREVIOUS. THE PATIENT FELL IN SUCH A WAY THAT THE BUCKET 'WENT UP IN THE PATIENT'S CROTCH, AND BRUISED THEIR LEG AND BACK.' THE PATIENT'S LEFT LEG AND BACK WERE SORE DOWN TO THEIR KNEE. IT WAS STATED THE PATIENT HAD AN APPOINTMENT WITH THE HEALTHCARE PROVIDER IN EARLY (B)(6), BUT DID NOT TALK ABOUT THE FALL. ANOTHER APPOINTMENT WAS SCHEDULED SIX WEEKS OUT, BUT THE PATIENT STATED THE PAIN WAS SO BAD THEY DID NOT KNOW IF 'THEY COULD MAKE IT.' A FLIP OF THE IMPLANTABLE NEUROSTIMULATOR (INS) DUE TO THE FALL HAD NOT BEEN CONFIRMED. ADDITIONALLY, THE PATIENT HAS HAD PAIN DOWN THEIR SCIATIC NERVE AND BACK FOR THE 'LAST FEW MONTHS.' IT WAS INDICATED BY THE PATIENT THAT THE INS HAD 'TURNED OVER' AND THEY COULD FEEL THE 'WIRES PROTRUDING ON THEIR SKIN.' THE PATIENT WAS ALSO WORRIED 'IT COULD BE A BLOOD CLOT IN THEIR LEG.' IT WAS FURTHER STATED THE INS WAS 'DEFINITELY ON A NERVE, PINCHING IT OR SOMETHING.' A BACK SURGERY WAS REPORTED TO HAVE OCCURRED IN (B)(6) 2012. IT WAS STATED THE PATIENT HAS 'DEGENERATIVE DISC AND THEY TRIMMED SOME BURS OFF OF IT.' CAT SCANS WERE TAKEN, BUT THE SCANS 'DID NOT SHOW ANYTHING.' ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30257 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1