BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2120195 · Received June 6, 2011

    Report

    Report Number
    3004209178-2011-04033
    Event Type
    Injury
    Date Received
    June 6, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULT WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION THE INS DISPLAYED THE END OF SERVICE MESSAGE ONE MONTH POST IMPLANT. ACCORDING TO THE PATIENT'S PROGRAMMING THE BATTERY SHOULD HAVE HAD 7-8 MONTHS OF USE. THE MANUFACTURER'S REPRESENTATIVE WAS UNABLE TO INTERROGATE THE DEVICE AND UNABLE TO RESTORE STIMULATION FOR THE PATIENT. THE DEVICE WAS REPLACED WITH A RECHARGEABLE BATTERY. NO PATIENT INJURY WAS REPORTED AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    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 27 YR Required Intervention PROGRAMMER: MODEL 37743, LOT# NKE156622N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565-65, LOT# V402325014