BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3241522 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12127
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    June 27, 2013
    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

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387-40, LOT # J0333616V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 7495-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT # VA08T93, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # VA0A3A0, PRODUCT TYPE LEAD PRODUCT ID NEU_ENS_STIMULATOR, SERIAL # UNKNOWN, PRODUCT TYPE EXTERNAL NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN CUT THE LEAD ON PURPOSE TO EXPLANT IT. IT WAS NOTED THAT THE OLD LEAD WAS THE LEAD WITH THE LOW IMPEDANCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS SCHEDULED TO HAVE THEIR LEFT LEAD REVISION THE NEXT MONDAY FOLLOWING THE REPORT. IT WAS STATED THE PATIENT HAD A LACK OF EFFICACY DUE TO PLACEMENT AND THEY WERE GOING TO ATTEMPT TO TRY A DIFFERENT LOCATION OR PLACEMENT FOR THE LEFT LEAD. IT WAS NOTED THE PATIENT HAD BETTER EFFECT ON THEIR RIGHT LEAD THAN THE LEFT LEAD. IT WAS LATER REPORTED CONTACTS 0 AND 1 HAD LOW IMPEDANCES OF 112 OHMS. IT WAS STATED THE LEAD REVISION WAS SUCCESSFUL AND THE PATIENT WOULD HAVE THEIR STAGE 2 PROCEDURE PERFORMED THE FOLLOWING WEEK SO THE PATIENT¿S DEVICE WAS NOT ON AT THE TIME OF REPORT. ADDITIONAL INFORMATION STATED THERE WERE LOW OUT OF RANGE IMPEDANCE VALUES. IT WAS NOTED THAT THE PATIENT HAD A LEFT LEAD REVISION DONE THE DAY OF REPORT AND THE PROXIMAL END OF THE LEAD WAS CUT. IT WAS STATED THE IMPLANTABLE NEUROSTIMULATOR (INS), THE DISTAL END OF THE LEAD, AND THE EXTENSION WERE LEFT IN THE PATIENT¿S BODY AND THEY WE SCHEDULED FOR THE THEIR STAGE 2 IMPLANT THE NEXT WEEK. IT WAS STATED A NEW LEAD WAS IMPLANTED AND IT WAS NOTED THAT THERE WAS NO ISSUE WITH THE FIRST LEAD. IT WAS ALSO STATED THE PATIENT HAD A TREMOR AND THE PHYSICIAN WANTED A BETTER RESULT AND WAS GETTING A HIGHER SETTING. IT WAS NOTED THAT THE PHYSICIAN TESTED WITH AN EXTERNAL NEUROSTIMULATOR (ENS) AT 6 V AND IT WAS ¿NOT GOOD EFFICIENCY¿ SO THE LEAD WAS MOVED DEEPER AND MORE POSTERIOR. REPORTEDLY, THE PHYSICIAN CONFIRMED WITH AN X-RAY THAT ¿ALL LOOKED GOOD¿ BUT THE PHYSICIAN WANTED BETTER EFFICIENCY AND REMOVED THE FIRST LEAD AND IMPLANTED THE SECOND LEAD IN THE SAME LOCATION WITH THE SAME RESULT. IT WAS NOTED THERE WAS NOTHING WRONG WITH THE FIRST LEAD. IT WAS ALSO REPORTED THE INITIAL IMPEDANCE FOR THE LEFT LEAD WAS 112 OHMS ON ELECTRODES 0 AND 1. IT WAS REPORTED THE PATIENT WAS DOING ¿FINE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340975 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention