BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 2032526 · Received March 24, 2011

    Report

    Report Number
    9614453-2011-02275
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    December 15, 2010
    Report Date
    March 9, 2011
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR (INS) MODEL 7428 SERIAL NUMBER (B)(4) DETERMINED NORMAL IMPEDANCES ON EACH ELECTRODE PAIR, GOOD, STABLE OUTPUT WERE OBSERVED ON EACH ELECTRODE PAIR AND THE INS WAS FUNCTIONALLY OKAY. NO SIGNIFICANT ANOMALIES WERE FOUND. ANALYSIS O/EXTENSION MODEL 7482 SERIAL NUMBER (B)(4) DETERMINED THE EXTENSION WAS /FUNCTIONALLY OKAY BUT CUT THROUGH (SUSPECTED EXPLANT DAMAGE). NO SIGNIFICANT ANOMALIES WERE FOUND ANALYSIS OF EXTENSION MODEL 7482 SERIAL NUMBER (B)(4) DETERMINED THE EXTENSION WAS FUNCTIONALLY OKAY BUT CUT THROUGH (SUSPECTED EXPLANT DAMAGE). NO SIGNIFICANT ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748295, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A DEFECTIVE DEVICE. PARESTHESIA WAS INDUCED BY PRESSURE ON IMPLANTABLE NEURO STIMULATOR (INS) AT CONTACT 7. LEFT IMPEDANCE WAS GREATER THAN 4,000 OHMS. THE DEVICE WAS EXPLANTED. ON (B)(6) 2011 A RE-IMPLANTATION OF STIMULATOR AND BOTH EXTENSIONS WAS PERFORMED. THE EVENT REQUIRED HOSPITALIZATION OR PROLONGATION OF HOSPITALIZATION. THE EVENT WAS UNLIKELY OR UNRELATED TO THE SURGERY, STIMULATION, SYSTEM, MEDICATION, OR PRE-EXISTING/UNDERLYING DISEASE. THE OUTCOME RESOLVED COMPLETELY.

    Description of Event or Problem · 1

    RECEIVED INFO THE PT EXPERIENCED A LOSS OF THERAPEUTIC STIMULATION AND A RETURN OF INCREASED TREMORS. PT ALSO REPORTED AN ELECTRICAL SHOCK WHEN BENDING DOWN. THE PHYSICIAN ASSUMED A FRACTURED LEAD. IMPEDANCES WERE >4000 OHMS FOR THE LEFT BODY SIDE/RIGHT HEMISPHERE. DURING THE REVISION, A SCREW IN THE CONNECTOR OF THE IPG WAS FOUND NOT COMPLETELY FIXED. AFTER FIXATION, IMPEDANCES WERE STILL >4000 OHMS. THE EXTENSIONS WERE REPLACED AND IMPEDANCES STILL ABNORMAL WITH THE "OLD" IPG. THE IPG WAS REPLACED AND ALL IMPEDANCES WERE WITHIN NORMAL. THE LEADS WERE NOT REPLACED. AFTER SURGERY, THE MEDICAL PROBLEMS RESOLVED AND THE PT RECOVERED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R EXPLANTED:| EXTENSION: MODEL 7482, LOT # NHU179889V| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT # NHU179812V