BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA SR

    MDR report key: 2770958 · Received October 3, 2012

    Report

    Report Number
    2647346-2012-01678
    Event Type
    Death
    Date Received
    October 3, 2012
    Date of Event
    March 29, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. ATTEMPT(S) FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESS AND CONSIDERED ACCORDINGLY. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) WAS RETURNED FROM A COMPETITOR WITH NO INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURER'S DATA BASE INDICATED THE PATIENT DIED APPROXIMATELY SIX MONTHS POST IMPLANT OF THE IPG. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THE EVENT. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADSR01

    Patients

    Seq Age Sex Outcome Treatment
    1 100 YR Death 1226T COMPETITOR IMPLANTABLE PACING LEAD