BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2895409 · Received January 3, 2013

    Report

    Report Number
    3004209178-2013-00119
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 12, 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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), LOT # V248458, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V280352, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY PRIOR TO THE REPORT A PATIENT HAD A REVISION FOR THE 8TH TIME. IT WAS STATED "THE CONNECTION KEPT GOING BAD." IT WAS NECESSARY TO "TUNNEL UNDER HIS SKULL BECAUSE THE SUTURE HAD NEVER HEALED." IT WAS COMMUNICATED THAT WHEN THE DEVICE WAS PROGRAMMED THE PATIENT WAS "1/2 DOPED UP." THE PATIENT WAS CURRENTLY GETTING BUZZING/STIMULATION IN HIS LEFT SIDE, HIS LEFT EYE WAS "OUT OF WHACK," HE WAS "SEEING DOUBLE," AND WHEN HE TURNED HIS HEAD TO THE RIGHT HE FELT A NUMBING SENSATION ON HIS LEFT SIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT BETWEEN 2009 AND 2012 THE PATIENT HAD 8 SURGERIES REGARDING CORRECTING THE IMPLANTABLE NEUROSTIMULATOR (INS)/LEADS BECAUSE THE ¿LEAD TO THEIR BRAIN KEPT GETTING INFECTED.¿ IT WAS NOTED THAT THE PATIENT REVISED THE STATEMENT AND SAID THAT ¿IT WAS NOT AN INFECTION; IT WAS THE PATIENT¿S IMMUNE SYSTEM REJECTING THE WIRING.¿ IT WAS NOTED THAT THE CURRENT IMPLANT HAD NO PROBLEMS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE DEVICE WAS REVISED BECAUSE THE ¿CONNECTION BETWEEN THE PATIENT¿S CHEST AND HIS BRAIN KEPT GOING BAD.¿ THE HEALTH CARE PROFESSIONAL TUNNELED A HOLE UNDERNEATH THE PATIENT¿S SKULL AND PUT ¿THAT WIRE UNDERNEATH THERE SO IT WOULD NOT SIT ON TOP OF HIS SKULL.¿ THE PROBLEM WAS ¿WHERE THE SUTURE WAS OVERLAPPING¿ AND THE INCISION "WOULD NEVER HEAL." ADDITIONAL INFORMATION REPORTED THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT WAS TREATED WITH ANTIBIOTICS, AND THE LEAD AND EXTENSION WERE REPLACED. IT WAS CLARIFIED THAT THE LEAD AND EXTENSION WERE NOT TUNNELED UNDER THE SKULL. THE PATIENT WAS CURRENTLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3102 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Other| R