BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2081445 · Received April 22, 2011

    Report

    Report Number
    3004209178-2011-03028
    Event Type
    Malfunction
    Date Received
    April 22, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A SHOCKING OR JOLTING SENSATION FOLLOWING A FALL. THE PT FELL ON (B)(6) 2011 AND SINCE THEN, WHEN THE PT TURNED ON THEIR DEVICE, THEY FELT A SHOCKING SENSATION. THE PT WENT TO ER (B)(6) 2011 AND WAS GIVEN PAIN/MUSCLE RELAXERS AND SENT HOME. THE PT WAS SCHEDULED TO SEE THEIR HCP ON (B)(6) 2011. THE PT WAS AT HOME AT THE TIME OF THE REPORT. ADDITIONAL INFO WAS REQUESTED.

    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 EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565-65, LOT # V383399033| PROGRAMMER: MODEL 37743, LOT # NKE147020N| IMPLANTED: