BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1099277 · Received August 6, 2008

    Report

    Report Number
    6000032-2008-04732
    Event Type
    Injury
    Date Received
    August 6, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 9, 2008
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., MED REL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT HAD A LEAD REVISION. THE SURGERY WAS ABOUT 4-5 MONTHS AGO. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MFR REPORT # 6000032-2008-01166.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXTENSION MODEL 7482| EXPLANTED| LEAD MODEL 3387| EXPLANTED