BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2060931 · Received March 14, 2011

    Report

    Report Number
    3004209178-2011-01885
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFORMATION THE PATIENT HAD A LOSS OF STIMULATION ON THE RIGHT SIDE OF HER BODY. MANUFACTURER'S REPRESENTATIVE MET WITH THE PATIENT AND INTERROGATED THE DEVICE. CONTACTS 8, 9, 10, 14 AND 15 SHOWED IMPEDANCES OF OVER 10,000 OHMS. PATIENT WAS CURRENTLY PROGRAMMED WITH A BI-POLAR SETTING WITH NUMBER 14 AND 15 CONTACTS. SHE WAS REPROGRAMMED WITH A BI-POLE AT 11 AND 12 AND RECEIVED SUCCESSFUL THERAPEUTIC STIMULATION OF THE RIGHT SIDE. NO SURGERY IS SCHEDULED OR HAS BEEN REQUESTED AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR EXPLANTED:| LEAD: MODEL 39565-30, LOT# N137590001| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD063015N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB026722V| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB026267V