BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2223855 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06555
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 30, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S STIMULATOR WAS EXPLANTED ON (B)(6) 2011. THE PT WANTED THE STIMULATOR REMOVED BECAUSE SHE WAS DIAGNOSED WITH BREAST CANCER AND COULD NOT HAVE AN MRI WITH THE SYSTEM. THERE WAS NO PT INJURY REPORTED. THE PT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention LEAD: MODEL 3778, LOT# V523755039| LEAD: MODEL 3778, LOT# V090745010| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE143245N