BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2073592 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-03109
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    August 2, 2010
    Report Date
    April 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIOSN CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): FINAL ANALYSIS OF NEUROSTIMULATOR MODEL 7426 (LOT # NFW148035H) SHOWED NO SIGNIFICANT ANOMALIES; THE IPG WAS FUNCTIONALLY OK. THE INS (IMPLANTABLE NEURO STIMULATOR) OUTPUT WAS TESTED AT THE DISTAL END OF A KNOWN GOOD LEAD. GOOD, STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR ON AN OSCILLOSCOPE, ACROSS A 510 OHM LOAD, CONNECTED TO THE DISTAL END OF THE EXTENSION. THERE WERE NO ISSUES WHEN PRESSING ON THE INS CAN. THERE WAS A BREACHED CUT IN SETSCREW GROMMET # 0 AND 1; COSMETIC CUT IN SETSCREW GROMMETS # 0 AND 1; # 0, 1 AND 3 SETSCREW GROMMETS WERE LOOSE; AND ALL SETSCREWS WERE BACKED OUT TOO FAR.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. IN LATER REPORTING IT WAS NOTED THAT THE PT WAS EXPERIENCING INCREASING TREMOR BILATERAL UPPER EXTREMITIES. THE LEFT IPG WAS REPLACED WITH GOOD CONTROL OF THE PT'S RIGHT HAND POSTURAL AND ACTION TREMOR. THE CAUSE OF THE EVENT WAS ATTRIBUTED TO THE IPG. THE PT OUTCOME WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIOSN CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention EXPLANTED:| LEAD: MODEL 3387, LOT# L72454| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU174565V| IMPLANTED: