BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3234099 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11977
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389S-40 LOT# V333264, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3389S-40 LOT# V386595, IMPLANTED: 2010 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 7426 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3550-05 LOT# N243723, IMPLANTED: 2010 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3550-05 LOT# N244450, IMPLANTED: 2010 (B)(6); PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A STROKE ABOUT A MONTH PRIOR TO THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333977 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Other