BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3770072 · Received April 24, 2014

    Report

    Report Number
    6000153-2014-00076
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 2, 2014
    Report Date
    January 5, 2017
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT # VA0B8HM, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A BLEED IN THE AREA OF THE LEAD TIP IN THE LEFT HEMISPHERE. THE PATIENT HAD RIGHT SIDED WEAKNESS WHILE IN RECOVERY. X-RAYS WERE TAKEN. LATER THAT DAY IT WAS REPORTED THAT THERE WAS A BRAIN BLEED AFTER LEAD PLACEMENT TWO DAYS PRIOR. TO THE REPORTER¿S KNOWLEDGE THE PATIENT WAS STABLE, BUT STILL HAD RIGHT SIDE WEAKNESS. THE PATIENT WAS AT THE HOSPITAL AND IT WAS NOTED THAT THIS NEUROSURGEON HAD NOT HAD THIS OCCUR BEFORE. FOUR DAYS LATER THE REPORTER DID NOT HAVE INFORMATION ON INTERVENTIONS TAKEN OR PLANNED. THE REPORTER DID NOT KNOW HOW THE PATIENT WAS DOING. THE PATIENT WAS NOT RECEIVING THERAPY. IT WAS NOTED THAT THE EXTENSIONS HAD NOT BEEN IMPLANTED. LATER THAT DAY IT WAS REPORTED THAT THE BLEED WAS DETECTED ON A CT-SCAN. THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD ALSO NOT BEEN IMPLANTED YET. SIX DAYS LATER IT WAS CLARIFIED THAT THIS WAS AN INITIAL LEAD IMPLANT. BOTH LEADS REMAINED IN PLACE AND THE EXTENSIONS AND INS WOULD BE IMPLANTED PENDING THE PATIENT¿S RECOVERY AND REHAB. THE BLEEDING HAD RESOLVED, BUT THE PATIENT WAS STILL EXPERIENCING LEFT SIDED WEAKNESS. THE PATIENT WAS IN REHABILITATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS OTHER MEDICAL ISSUES. THIS WAS NOT DUE TO THE MANUFACTURER EQUIPMENT OR IMPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP). IT WAS REPORTED THAT THE PATIENT HAD A STROKE FROM THE DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE. IT WAS THEN STATED THAT THE HCP WAS NOT SURE IF IT WAS DURING THE PROCEDURE OR AFTER AS IT OCCURRED 2 YEARS AGO AND THE PATIENT WAS IMPLANTED IN (B)(6) 2015. IT IS UNKNOWN WHEN THE ISSUE OCCURRED. FOLLOW-UP WITH THE HCP INDICATED THAT THE STROKE WAS OBSERVED POST-OPERATIVELY ON (B)(6) 2014. THE ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE STROKE INCLUDED MEDICATION, OCCUPATIONAL THERAPY, AND PHYSICAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248405 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387S-40 VA0H1PY

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization