BEUDAMED
    FDA Adverse Event Death Summary report: N

    SENSIA DR

    MDR report key: 3220838 · Received July 11, 2013

    Report

    Report Number
    3004209178-2013-11613
    Event Type
    Death
    Date Received
    July 11, 2013
    Date of Event
    May 21, 2013
    Report Date
    July 23, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ATTEMPTS FOR ADDITIONAL INFORMATION WERE UNSUCCESSFUL. HOWEVER, IF REQUESTED ADDITIONAL INFORMATION IS SUBSEQUENTLY RECEIVED IT WOULD BE PROCESS AND CONSIDERED ACCORDINGLY. CONCOMITANT PRODUCT:S IMPLANTABLE TACHY LEAD, IMPLANTED: (B)(6) 2006, 407652 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2006. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4). THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE RETURNED DEVICE INDICATED NORMAL BATTERY DEPLETION.

    Description of Event or Problem · 1

    AN IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS RETURNED FROM A FUNERAL HOME WITH LITTLE INFORMATION. INFORMATION IDENTIFIED IN THE MANUFACTURE¿S DATABASE/PAPERWORK INDICATED THE PATIENT DIED APPROXIMATELY 7 MONTHS POST IMPLANT OF THE IPG SYSTEM. THE CAUSE OF DEATH WAS REPORTED AS: RESPIRATORY ARREST, SEPSIS OF UNKNOWN ORGANISMS, CORONARY ARTERY DISEASE AND CHRONIC OBSTRUCTIVE PULMONARY DISEASE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321191 SENSIA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO SEDR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00091 YR Death