BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2092141 · Received April 27, 2011

    Report

    Report Number
    3004209178-2011-03129
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    April 11, 2011
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. SHE WAS REPROGRAMMED ABOUT (B)(6) AGO AND SYMPTOMS BECAME WORSE NOT BETTER. IT WAS NOTED SHE HAS A RARE MEDICAL CONDITION RELATED TO A STROKE AND IT HAD BEEN VERY CHALLENGING WITH ALL THE TREATMENTS THAT HAVE BEEN DONE. THE HEALTHCARE PROVIDER CONFIRMED THAT SHE EXPERIENCED NO SYMPTOMS. HER DEVICE WAS REPROGRAMMED ON (B)(6) 2008 AND SHE WAS SUPPOSED TO CALL BACK. PT OUTCOME WAS NOTED AS NO INJURY. LATER IT WAS REPORTED THAT THE PT NEVER EXPERIENCED THERAPEUTIC EFFECT. THE PT PROGRAMMER WOULD NOT DISPLAY IF THE DEVICE WAS ON OR OFF. THE HEALTHCARE PROVIDER REPORTED THAT THE PT DID NOT FEEL THE INS WAS EFFECTIVE. THE INS WAS REPROGRAMMED ON (B)(6) 2009. THE INS TURNED OFF SEVERAL TIMES WITH IMMEDIATE INCREASED MOVEMENTS. EACH TIME THE INS WAS TURNED BACK ON, THE MOVEMENTS CEASED. PT OUTCOME WAS STILL NO INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A, LOT# NHU178413V| EXPLANTED:| EXTENSION: MODEL 7482A, LOT# NHU178414V| IMPLANTED:| LEAD: MODEL 3387S, LOT# V120700| LEAD: MODEL 3387S, LOT# V120700| IMPLANTED:| EXPLANTED: