BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1871049 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-07824
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 14, 2010
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT REC'D AN END OF LIFE (EOL) MESSAGE. A LONGEVITY CALCULATION WAS PERFORMED TO ESTIMATE THE BATTERY LIFE OF THE INS. THE LONGEVITY CALCULATION INDICATED THAT THE BATTERY SHOULD HAVE LASTED, APPROX, AN ADDITIONAL EIGHT MONTHS. THE BATTERY ONLY LASTED TWO MONTHS. IMPEDANCE VALUES COULD NOT BE ERASED DUE TO THE EOL STATUS. IT WAS LATER REPORTED THAT, INITIALLY, THE EXTENSIONS WERE TESTED IN THE SNAP LID, TO RULE OUT A SHORT CIRCUIT. THE EXTENSIONS IN THE SNAP LID WERE SWITCHED AND THEN THE 3 AND 8 ELECTRODES HAD IMPEDANCE READINGS GREATER THAN 10,000 OHMS. THE PT'S INS WAS REPLACED AND IMPEDANCES WERE CHECKED AGAIN. AFTER CHECKING ALL OF THE REFERENCE ELECTRODES, ONLY ELECTRODES 0 AND 11 HAD IMPEDANCE READINGS GREATER THAN 10,000 OHMS. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT REC'D AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 85 YR Required Intervention LEAD: MODEL 3998, LOT # V011406V01| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT # NKB006486V| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT # V279839| IMPLANTED:| LEAD: MODEL 3888, LOT # V434087| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE149188N| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT # NKB011764N| EXPLANTED: