BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8196198 · Received December 26, 2018

    Report

    Report Number
    3004209178-2018-28336
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Report Date
    February 8, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761071
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40, LOT# VA08KLN, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V233444, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR ESSENTIAL TREMORS, MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT¿S SON HAD INFORMED THE REP ON 12/19/2018 THAT THEIR MOTHER¿S RIGHT DBS SYSTEM HAD BEEN TURNED OFF FOR YEARS AND THERE HAD BEEN PROBLEMS WITH IT. THEY DID NOT HAVE ANY DETAILS OR ANY ADDITIONAL INFORMATION. IT WAS STATED THAT THE IMPLANT HAD REMAINED IMPLANTED BUT WAS OUT OF SERVICE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP STATED THAT THE CAUSE OF THE RIGHT SIDE DBS SYSTEM WAS BECAUSE LEAD'S PLACEMENT WAS NOT ACCURATE AND THERE WAS SOME BLEEDING DURING THE STAGE 1. NO INTERVENTIONS HAVE BEEN TAKEN TO RESOLVE THE ISSUE, HOWEVER THEY DECIDED TO LEAVE IT IMPLANTED BUT TURN IT OFF. THE ISSUE HAS NOT BEEN RESOLVED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1034932 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761071

    Patients

    Seq Age Sex Outcome Treatment
    1