BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA DR

    MDR report key: 3221645 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-11638
    Event Type
    Death
    Date Received
    July 11, 2013
    Date of Event
    March 29, 2013
    Report Date
    July 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    5076-58 IMPLANTABLE PACING LEAD (B)(4), IMPLANTED: 2013 (B)(6), 5076-52 IMPLANTABLE PACING LEAD IMPLANTED: 2013 (B)(6). F(B)(4).

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED FROM A MANUFACTURER REPRESENTATIVE. INFORMATION IDENTIFIED IN THE MANUFACTURE¿S DATABASE/PAPERWORK INDICATED THE PATIENT DIED APPROXIMATELY 2 MONTHS POST IMPLANT OF THE IPG SYSTEM. PER THE FUNERAL HOME, THE CAUSES OF DEATH ARE LISTED AS 1) END STAGE RENAL FAILURE (ESRF) 2) ENDOCARDITIS 3) SICK SINUS SYNDROME. PER THE IMPLANT DOCTOR'S NURSE, THE DEVICE WAS EXPLANTED APPROXIMATELY 5 WEEKS AFTER IMPLANT BECAUSE, THE PATIENT WAS FOUND TO HAVE (B)(6). SHE DID NOT KNOW WHERE THE (B)(6) WAS LOCATED. ALSO, AN ECHOCARDIOGRAM SHOWED RIGHT ATRIAL (RA) LEAD VEGETATION. AN EXTRACTION WITH POCKET DEBRIDEMENT WAS DONE TO DECREASE THE RISK OF CELLULITIS. THE PATIENT DIED APPROXIMATELY 3 WEEKS AFTER THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320001 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death