BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2223873 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06542
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS OF THE STIMULATOR REVEALED IT WAS FUNCTIONALLY OKAY. GOOD, STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE EVENT RESOLVED WITHOUT SEQUELA AS OF (B)(6)-2012.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE PATIENT'S ANXIETY OCCURRED WHEN IN LARGER GROUPS. REPROGRAMMING OF THE IMPLANTABLE NEUROSTIMULATOR WAS PERFORMED ON (B)(6) 2010 AND (B)(6) 2012. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED, IMPEDANCES WERE <250 OHMS BETWEEN MULTIPLE ELECTRODES, AND IMPEDANCES BETWEEN ELECTRODES 0 AND 3 WERE >4000 OHMS. THE PT ALSO HAD ANXIETY. THE DEVICE WAS REPROGRAMMED, AND THE PT WAS GIVEN PSYCHOTROPIC MEDICATION. THE RESULTS OF THE REPROGRAMMING WERE UNK. AN X-RAY WAS PERFORMED AND THE RESULTS SHOWED THE LEAD/EXTENSION CONNECTION WAS "VERY LOW" AS IT WAS LOCATED BELOW THE PT'S EAR. THE X-RAY ALSO SHOWED THE LEAD WAS NOT FULLY INSERTED INTO THE EXTENSION. THE '0' ELECTRODE WAS LEFT INSERTED INTO THE EXTENSION, THUS CREATING A MIS-ALIGNMENT OF ELECTRODES IN WHICH 0=1, 1=2, 2=3, AND 3=OPEN. THERE WAS ALSO A DISTINCTIVE "BEND" OR "KINK" IN THE LEAD NEAR THE EXTENSION. THE DEVICE WAS REPLACED DUE TO NORMAL BATTERY DEPLETION AND THE HIGH IMPEDANCES. IT WAS VERBALLY INDICATED THE ELECTRODE MIS-ALIGNMENT WAS CORRECTED DURING THE REPLACEMENT SURGERY, BUT THERE WAS NO DOCUMENTATION SHOWING THIS OCCURRED. IT WAS NOT CLEAR IF LEAD/EXTENSION CONNECTION LOCATION WAS ALSO CORRECTED. THERE WAS NO PT INJURY AND THE PT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED IMPEDANCES ON THE RIGHT LEAD MEASURED 54 OHMS. NO ACTION WAS TAKEN. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PATIENT'S ANXIETY WAS CONSIDERED AN ONGOING EVENT AS OF (B)(6)-2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention STIM ACCESSORY: MODEL 3550-05, LOT# N215321| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU198733V| EXPLANTED:| EXPLANTED:| EXPLANTED:| LOT# NFD112273H| IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL 3550-05, LOT# N215321| IMPLANTABLE NEURO STIMULATOR: MODEL 7428| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| LOT# N116040| EXTENTION: MODEL 7482A51, LOT# NHU198734V| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3391S-40, LOT# V159369| IMPLANTED:| LOT# N152155| UNKNOWN CONVERSION TYPE: MODEL 3550-09| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| UNKNOWN CONVERSION TYPE: MODEL 3550-09| LEAD: MODEL 3391S-40, LOT# V159369| IMPLANTED: