BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2626182 · Received June 22, 2012

    Report

    Report Number
    3004209178-2012-04764
    Event Type
    Injury
    Date Received
    June 22, 2012
    Report Date
    May 29, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A66, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 7482A51, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 3387S-40, LOT# V022878, SERIAL# IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 3387S-40, LOT# V022878, SERIAL# IMPLANTED: (B)(6) 2007, EXPLANTED: PRODUCT TYP LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A MEDICAL OR THERAPY PROBLEM. IT WAS REPORTED THE PATIENT WAS HAVING SOME TACHYCARDIA AND THE HEALTH CARE PROFESSIONAL WANTED TO DO AN EKG BECAUSE OF THE SYMPTOMS HE PORTRAYED WHILE IN THE HCP OFFICE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other