BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 4286527 · Received December 1, 2014

    Report

    Report Number
    3004209178-2014-22300
    Event Type
    Injury
    Date Received
    December 1, 2014
    Date of Event
    November 3, 2014
    Report Date
    November 6, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389S-40, LOT# V082874, IMPLANTED: 2008 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT¿S ENTIRE SYSTEM WAS EXPLANTED DUE TO INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE, AND THE INS BECAME EXPOSED ON THE RIGHT CHEST. IT WAS NOTED, THE DEVICE WOULD NOT BE RETURNED, AND THAT THE PATIENT HAD BEEN ADMINISTERED PERIOPERATIVE ANTIBIOTICS. THE MANUFACTURER REPRESENTATIVE LATER STATED, THE INS INFECTION WAS ON THE LEFT CHEST. THE INFECTION WAS RESOLVED THROUGH TREATMENT WITH ANTIBIOTICS, AND THE PATIENT RECOVERED AND WAS DISCHARGED THE NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773717 KINETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R