BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1766808 · Received July 20, 2010

    Report

    Report Number
    3004209178-2010-05594
    Event Type
    Malfunction
    Date Received
    July 20, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED HIGH IMPEDANCES ON LEFT SIDE OF >4,000 OHMS AND <15UA: C0, C3, 13, 23, 03. ALONG WITH 1378 OHMS AND 17UA: C1, 12, 2074 OHMS AND <15UA: C2, 01, 02, 03. PT IS PROGRAMMED 3+2- AND 2.8V/60PW/190HZ. RIGHT SIDE: 1028 OHMS AND 17UA: C4, C5, C6, C7; 1378 OHMS AND 17UA: 45, 56, 67; 2074 OHMS AND <15UA: 46, 47, 57. PT IS PROGRAMMED 7-5+6+ 1.7V/60PW/190HZ. HCP STATES IMPEDANCE TEST WAS DONE AT 4V. PT HAD SEVERAL OCCASIONS WHERE HE WAS HITTING HIS HEAD SEVERAL TIMES BETWEEN LEAD IMPLANT. ADDITIONAL INFO WAS REQUESTED AND WILL BE PROVIDED WHEN IT BECOMES AVAILABLE.

    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 51 YR LEAD: MODEL 3387, LOT# J0204989V| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NGK015926N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0204989V| EXTENSION: MODEL 7482, LOT# NGK015925N| EXPLANTED:| IMPLANTED:| LOT# NFW109527H| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426