BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3927517 · Received July 10, 2014

    Report

    Report Number
    3004209178-2014-12847
    Event Type
    Injury
    Date Received
    July 10, 2014
    Report Date
    June 20, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3387S-40, LOT# V032332, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V032332, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40. SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7436, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 FOR WEAKNESS, AKINESIA, AND DEMENTIA THAT WAS PREVENTING THE PATIENT FROM TAKING HIS PARKINSON¿S DISEASE MEDICATIONS. THE REPORTER NOTED THAT THE PATIENT DID NOT SPEAK AND DID NOT SEEM VERY COHERENT. THE PATIENT HAD ADVANCED PARKINSON¿S DISEASE AND THESE SYMPTOMS HAD BEEN GRADUALLY GETTING WORSE. IT WAS NOT CLEAR IF THE SYMPTOMS WERE RELATED TO THE THERAPY. PRIOR TO HOSPITALIZATION THE PATIENT HAD BEEN IN A CARE FACILITY DUE TO HIS PARKINSON¿S DISEASE. PER THE CLINICIAN PROGRAMMER THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON AND CHARGED TO 100%. THE REPORTER NOTED THAT RECHARGE STATS START FROM(B)(6) 2000. THE INS DATE WAS SHOWING ON THE CLINICIAN PROGRAMMER AS (B)(6) 2000 WITH OTHER RECHARGE DATES IN 2000. EACH RECHARGE LASTED ABOUT A HALF HOUR AND THE PATIENT WAS AT 100% AT THE END OF EACH SESSION. THE REPORTER ALSO READ A LOW, OUT OF RANGE IMPEDANCE VALUE. ALL IMPEDANCES WERE WITHIN NORMAL RANGE, EXCEPT COMBINATION 6 AND 7, WHICH WAS 82 OHMS. THE PAIR WAS NOT BEING USED IN PROGRAMMING. ABOUT TWO AND A HALF WEEKS LATER IT WAS REPORTED THAT THE IMPEDANCE ISSUE WAS FIRST NOTED ON THE ORIGINAL REPORT DATE. THE IMPEDANCE ON COMBINATION 6 AND 7 WAS 78 OHMS AND HAD NOT RESOLVED. THE CAUSE OF THE IMPEDANCE ISSUE WAS NOT DETERMINED AND IT WAS UNKNOWN IF THERE WERE ANY LEAD FRACTURES. THE PATIENT OUTCOME WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405254 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization