BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2011484 · Received March 7, 2011

    Report

    Report Number
    3004209178-2011-01702
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    February 11, 2011
    Report Date
    February 21, 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
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL DEVICE ANALYSIS WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP MEDWATCH REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE AND/OR WHEN ADDITIONAL INFORMATION IS RECEIVED FROM THE HCP.

    Description of Event or Problem · 1

    IT WAS STATED THAT THE PATIENT FELL. NO OTHER DETAILS WERE PROVIDED. THE LEAD WAS RETURNED TO THE MANUFACTURER. THE MANUFACTURER DEVICE TRACKING SYSTEM INDICATED THE LEAD WAS REPLACED. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.

    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 50 YR Required Intervention EXPLANTED:| LEAD: MODEL 3998, LOT# V113343| EXTENSION: MODEL 37081, LOT# NJB028826V| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB030654V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3998, LOT# V113343| EXTENSION: MODEL 37082, LOT# NKB011251N| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB012274N| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE105821N| EXPLANTED: