BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4760127 · Received May 8, 2015

    Report

    Report Number
    3004209178-2015-08785
    Event Type
    Injury
    Date Received
    May 8, 2015
    Report Date
    May 1, 2015
    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

    CONCOMITANT PRODUCTS: PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387S-40, LOT# V951526, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3387S-40, LOT# VA00V17, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT NEW LEADS WOULD BE IMPLANTED ON 2015-(B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. IMAGING WAS DONE OF THE SYSTEM AND IT WAS FOUND THAT ONE SIDE OF THE SYSTEM HAD THE LEAD SUPERFICIAL TO WHERE IT SHOULD BE LOCATED, APPROXIMATELY 0.5 CENTIMETERS, AND THE OTHER SIDE WAS ABOUT 1 CENTIMETER SUPERFICIAL TO WHERE IT SHOULD BE LOCATED. THE LEADS WERE REMOVED ON (B)(6) 2015. WHEN THE LEADS WERE REMOVED IT WAS FOUND THAT, EVEN THOUGH THE STIMLOCK SUPPORT WAS CLOSED, THEY WERE STILL ABLE TO PULL THE LEADS OUT AND THUS WERE CONCERNED THERE WAS AN ISSUE WITH THE STIMLOCK SYSTEM. THE PATIENT WAS GOING TO HAVE A REVISION ON (B)(6) 2015 TO PULL THE STIMLOCKS. THE PATIENT OUTCOME WAS NOT YET AVAILABLE SINCE A LATER SURGERY WAS SCHEDULED, SO ADDITIONAL INFORMATION WILL BE REQUESTED AT THE APPROPRIATE TIME. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT. REFER TO MANUFACTURING REPORT #3004209178-2015-08784 AS THE PATIENT HAD TWO INSS AND BOTH LEADS HAD PLACEMENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304358 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention