BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 3052444 · Received April 11, 2013

    Report

    Report Number
    6000032-2013-00085
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Report Date
    March 26, 2013
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3389-40, LOT# J0455041V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 3389-40, J0546567V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S DOCTOR MEASURED A PATIENT'S THERAPY IMPEDANCE AND THE VALUE WAS GREATER THAN 4000 OHMS AND THE CURRENT WAS LESS THAN 15 AMPS. IT WAS NOTED THAT THE DOCTOR WONDERED IF SHE'D DONE SOMETHING WRONG. IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS OFF WHEN HE SAW THE DOCTOR AND THE PATIENT DIDN'T KNOW WHY. THE REPORTER STATED THAT THE PATIENT HAD NOTICED THAT HIS TREMOR SEEMED A LITTLE BIT WORSE AND THE DOCTOR TURNED STIMULATION BACK ON. IT WAS NOTED THAT THE PATIENT DIDN'T GET A "BIG SURGE" OR FEEL THE DEVICE TURN ON. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF DURING THE PATIENT¿S FIRST VISIT TO THE CLINIC. IT WAS NOTED THAT THE HEALTH CARE PROFESSIONAL TURNED THE DEVICE ON AND THERE WAS AN IMPROVEMENT OF SYMPTOMS. NO SURGICAL INTERVENTION WAS PERFORMED. SIGNS AND SYMPTOMS ASSOCIATED WITH THE REPORTED EVENT WERE INCREASED ¿PD¿ SYMPTOMS. THERE WAS NO PATIENT INJURY OR HOSPITALIZATION REQUIRED. IT WAS NOTED THAT THE PATIENT WAS UNSURE HOW LONG DEVICE HAD BEEN OFF OR WHAT TURNED THE DEVICE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156633 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT SOFAMOR DANEK PUERTO RICO MFG 7428

    Patients

    Seq Age Sex Outcome Treatment
    1