BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3211663 · Received July 8, 2013

    Report

    Report Number
    6000153-2013-00130
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    June 21, 2019
    Manufacturer
    NEURO - VILLALBA
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY, BUT HAD NOT SOUGHT FURTHER HELP.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) HAD TROUBLE WITH A LEAD CAP. THE REPORTER STATED THEIR HCP TRIED TO SNAP IT ON AND COULDN¿T GET IT TO HOOK. IT WAS NOTED THAT THE HCP "FINALLY GAVE UP" AND TOOK IT OFF AND PUT ON ANOTHER AND THEN GOT THAT ONE TO SNAP. IT WAS REPORTED THAT THE PATIENT DIDN'T KNOW IF IT MOVED THE WIRE INSIDE. IT WAS NOTED THE PATIENT¿S HCP SAID ONE OF THE WIRES WAS ¿CLOSER TO THE SIDE THAN IT SHOULD BE¿ AND MAY HAVE CAUSED THE PATIENT TO SHAKE MORE. THE REPORTER STATED THAT THE HCP HAD TO REDO THE LEADS BEFORE GETTING THE SECOND CAP ON. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM HEALTH CARE PROVIDER REPORTED THAT THE CAUSE OF CROOKED LEAD WAS NOT DETERMINED. THE LEADS CAUSED ALONG THE FRONTAL LUBES WITH THEIR TIPS IN THE VIM. THE PATIENT EXPERIENCED MUSCLE CONTRACTIONS THAT LED TO SPEECH AND GAIT DIFFICULTIES. IT WAS INDICATED THAT THE PATIENT HAD LEADS REMOVED AND HAD A NEW ONE PUT IN. THE PATIENT HAS NOT BEEN SEEN IN THE OFFICE YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309105 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY NEURO - VILLALBA 3387S-40 V378034

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention