BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6176304 · Received December 15, 2016

    Report

    Report Number
    3004209178-2016-26495
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    November 1, 2016
    Report Date
    December 14, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    UDI-DI
    00613994934604
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387S-40, LOT# V013793, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT'S SKIN OVER THE LEAD HAD ERODED, LEAVING THE LEAD EXPOSED ON THE RIGHT, BACK SIDE OF THE HEAD. THEY SAID THAT THE PATIENT'S GLASSES WERE RUBBING ON THE SKIN CAUSING THE EROSION OF THE COMPONENT. THE HCP STATED THAT THEY HAD PUT FOAM ON THE GLASSES TO HELP WITH THE RUBBING AND WANTED TO KNOW WHAT TO DO WITH THE LEAD. IT WAS REVIEWED THAT THEY NEEDED TO FOLLOW UP WITH THE PATIENT'S MANAGING HCP. THE ISSUE WAS NOTED AS SUDDEN. FOLLOW UP FROM THE MANAGING HCP REPORTED THE BATTERY AND CONNECTION WIRES WERE REMOVED FROM THE RIGHT CHEST. THEY NOTED THAT THE ISSUE WAS RESOLVED AND THEY HAD SURGICALLY REPAIRED THE ISSUE AND GAVE THE PATIENT IV ANTIBIOTICS. THE IMPLANTABLE NEUROSTIMULATOR (INS)WAS INDICATED FOR MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829917 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601 00613994934604

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention