BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3813619 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09055
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    October 27, 2011
    Report Date
    April 24, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT # V814474, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V814474, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION. THE INITIAL REPORTER WAS THE PATIENT'S WIFE, BUT NO NAME OR INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(4) 2014 THAT IMMEDIATELY AFTER IMPLANT, THE PATIENT EXPERIENCED ERRATIC BLOOD PRESSURE AND DELIRIUM. THE PATIENT HAD TO BE ADMITTED TO PHYSICAL REHAB AND HAD TO WEAR A ¿HOSPITAL-BED ALARM¿ AND WAS EVENTUALLY ¿STRAPPED TO THE BED.¿ THE REPORTER STATED THAT THE PATIENT¿S WIFE REPORTED THESE ISSUES TO THE HOSPITAL AT THE TIME. THE REPORTER STATED THAT THE DOCTOR SEEMED TO DISMISS THE WIFE¿S CLAIMS, BUT IT WAS ONLY ¿SECOND-HAND INFO.¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPORTER HAD NOT HEARD BACK FROM THE PATIENT. TO THE REPORTER¿S KNOWLEDGE THE CAUSE OF THE ERRATIC BLOOD PRESSURE AND ITS POTENTIAL RELATIONSHIP TO THE SYSTEM WAS NOT DETERMINED. THE PATIENT WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290357 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| O