BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2904826 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00371
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 748240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3387-40, LOT # J0306809V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT # J0306809V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD EXPERIENCED A SHOCKING OR JOLTING SENSATION FOLLOWING A FALL. THE PATIENT HAD A HISTORY OF HAVING FALLS, BUT NO DETAILS WERE AVAILABLE. THE PATIENT FELT SHOCKS IN HIS RIGHT ARM PRIMARILY AND POSSIBLY SOME SHOCKING IN HIS LEFT ARM, AS WELL. HE ALSO HAD 14 OTHER NEUROLOGICAL ISSUES GOING ON AS WELL, INCLUDING A HISTORY OF A STROKE, SO IT WAS HARD TO TELL WHAT AMOUNT OF BENEFIT HE WAS GETTING FROM THE STIMULATION THERAPY. ADDITIONALLY, IMPEDANCE VALUES OF >2000 OHMS ON ALL OF THE UNIPOLAR PAIRS WERE READ. THE CURRENT WAS REPORTED TO BE "7, 8 OR 9." IT WAS UNCLEAR WHAT UNITS THE CURRENT HAD BEEN MEASURED IN OR WHETHER VOLTAGE IN UNITS OF VOLTS HAD BEEN REALLY IMPLIED BY THAT. THERAPY IMPEDANCE WAS ALSO OUT OF RANGE WITH A LOW CURRENT VALUE AT AROUND 17UA, WHEN IT HAD BEEN AROUND 680-700 OHMS WITH A CURRENT OF 40-50UA. THE PATIENT HAD BEEN PROGRAMMED TO THE AMPLITUDE OF 1.8V, PULSE WIDTH OF 90US, AND THE RATE OF 185HZ. X-RAY ANALYSIS OF THE SYSTEM WAS BEING PLANNED TO SEE IF OPEN CIRCUITS COULD BE SEEN AND A REVISION WAS BEING PLANNED AS WELL THOUGH EXACT DATE HAD NOT BEEN ESTABLISHED YET. 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 ALSO REPORTED ON PATIENT'S OTHER INS IN REGULATORY REPORT # 3004209178-2013-00369.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11677 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1