BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2635378 · Received June 29, 2012

    Report

    Report Number
    3004209178-2012-04979
    Event Type
    Injury
    Date Received
    June 29, 2012
    Report Date
    June 1, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51 LOT# SERIAL# (B)(4) IMPLANTED: 2011-(B)(6) EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 7438 LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3387S-40 LOT# V791803 SERIAL# IMPLANTED: 2011-(B)(6) EXPLANTED: PRODUCT TYPE LEAD LEFT SIDE CONCOMITANT SYSTEM: PRODUCT ID 37603 LOT# SERIAL# (B)(4) IMPLANTED: 2012-(B)(6) EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3387S-40 LOT# V866904 SERIAL# IMPLANTED: 2012-(B)(6) EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 37642 LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37085-60 LOT# SERIAL# (B)(4) IMPLANTED: 2012-(B)(6) EXPLANTED: PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEVERE SPASM IN HER RIGHT ARM WHEN STIMULATION WAS TURNED ON. THE PATIENT'S PHYSICIAN HAD HER TURN OFF THE IMPLANTABLE NEUROSTIMULATOR (INS) UNTIL THE SPASMS WENT AWAY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2012-04977.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention