BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 3031214 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04490
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7428, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3387-40, LOT# J0451702V, PRODUCT TYPE: LEAD. PRODUCT ID 3387-40, LOT# J0451702V, PRODUCT TYPE: LEAD. PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 748240, SERIAL# (B)(4), PRODUCT TYPE; EXTENSION. PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE; PROGRAMMER, PATIENT. PRODUCT ID 7428, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3387-40, LOT# J0451702V, PRODUCT TYPE; LEAD. PRODUCT ID 3387-40, LOT# J0451702V, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (STIMULATOR 7428 INS, SERIAL # (B)(4)) FOUND IT TO HAVE REACHED A NORMAL END OF LIFE WITH NO TELEMETRY AND NO OUTPUT. ALL ELECTRODE PAIRS WERE USED FOR THE OUTPUT TEST. CONNECTOR MODULE WAS SCRATCHED. ACCESS HOLE ADHESIVE HAD A COSMETIC CUT. THE SETSCREW WAS BACKED OUT TOO FAR. SHIELD/CAN WAS SCRATCHED, HAD BURN MARKS (SUSPECTED CAUTERY), AND THE BATTERY WAS EXPANDED. INSULATION COATING WAS SCRATCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLLOWING HIGH IMPEDANCES OCCURRED WHEN CHECKING THE LEFT VENTRAL INTERMEDIATE NUCLEUS (VIM) LEAD: C <(>&<)> 0 18,092 OHMS C <(>&<)> 3; 5,423 OHMS 0 <(>&<)> 1 18,610 OHMS 0 <(>&<)> 2; 19,296 OHMS 0 <(>&<)> 3 26,538 OHMS 1; <(>&<)> 3 6,228 OHMS 2 <(>&<)> 3 5,776 OHMS ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. INFORMATION ON THE RIGHT SIDE IMPLANT WAS REPORTED IN MANUFACTURER'S REPORT # 3004209178-2013-04489.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134936 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention