BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA

    MDR report key: 2999790 · Received March 12, 2013

    Report

    Report Number
    9614453-2013-00560
    Event Type
    Death
    Date Received
    March 12, 2013
    Date of Event
    February 13, 2013
    Report Date
    April 23, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED. CONCOMITANT PRODUCT: C5076-58 IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) - THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A DUAL CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY TEN MONTHS POST THE DEVICE SYSTEM IMPLANT.

    Description of Event or Problem · 1

    A DUAL CHAMBER IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED TO THE MANUFACTURER FROM A FUNERAL HOME WITH NO INFORMATION. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY TEN MONTHS POST THE DEVICE SYSTEM IMPLANT. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103959 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Death 5076-52 IMPLANTABLE PACING LEAD