BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3260032 · Received August 1, 2013

    Report

    Report Number
    3004209178-2013-12643
    Event Type
    Injury
    Date Received
    August 1, 2013
    Date of Event
    March 26, 2010
    Report Date
    April 29, 2013
    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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387-40, LOT # J0545158V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT # J0527433V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL # NHU107904V, IMPLANTED: (B)(6) 2005, TYPE EXTENSION; PRODUCT ID 748251, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, SINCE THE PATIENT HAD A REPLACEMENT OF HIS IMPLANTABLE NEUROSTIMULATOR (INS) IN 2010 AND REPROGRAMMING IN (B)(6) 2012, THE THERAPY HAD NOT WORKED RIGHT. IT WAS STATED THAT HIS SYMPTOMS HAD GOTTEN WORSE SINCE LAST REPROGRAMMING. IT WAS STATED THAT THE PATIENT DIDN'T GET BETTER OR CHANGE. IT WAS REPORTED REPROGRAMMING HAD BEEN PERFORMED 3-4 TIMES A YEAR BUT IT HAD NOT WORKED. A LOSS OF THERAPEUTIC EFFECT WAS REPORTED. IT WAS LATER REPORTED THAT SINCE IMPLANT THAT PATIENT HAD INADEQUATE RELIEF. WHEN IMPEDANCE MEASUREMENTS WERE TAKEN, ALL BIPOLAR AND UNIPOLAR PAIRS READ THAT THEY WERE OVER 4,000 OHMS. THE TEST VOLTAGE WAS INCREASED TO 3.5V AND ONLY THE FOLLOWING PAIRS WERE HIGH: CASE AND ZERO, CASE AND ONE, CASE AND SEVEN, FOUR AND SIX, FOUR AND SEVEN, FIVE AND SIX, AND SIX AND SEVEN. WHEN ELECTRODES ZERO AND ONE WERE USED, THE PATIENT FELT SOME TINGLING. WHEN THE CASE AND FOUR WERE PROGRAMMED THE PATIENT GOT SOME TINGLING/RESPONSE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT HAD A REVISION PROCEDURE. THE PATIENT HAD AN X-RAY PRE-OPERATIVE, BUT DID NOT SEE ANY SEVERED PARTS IN THE SYSTEM. WHEN THE SURGEON WENT IN, HE COULD SEE THERE WAS AN ISSUE WITH ONE OF THE EXTENSIONS. THE PATIENT HAD BROKEN THE EXTENSION DUE TO FALLING. THAT EXTENSION WAS REPLACED. ON THE OTHER SIDE THE CONNECTION JUST NEEDED TO BE TIGHTENED. ALL IMPEDANCES WERE NOW NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360459 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention