BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA DR

    MDR report key: 2183295 · Received July 28, 2011

    Report

    Report Number
    6000094-2011-01289
    Event Type
    Death
    Date Received
    July 28, 2011
    Date of Event
    July 7, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. BATTERY VOLTAGE - BATTERY DEPLETION INDICATED/ERI (B)(4) ERI RECORDED ON (B)(4)-2011. BATTERY IMPEDANCE 10,202 OHMS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF "PRESYNCOPE SYMPTOMS." IT WAS FOUND THAT THE PATIENT'S DEVICE HAD BEEN AT THE ELECTIVE REPLACEMENT TIME FOR 5 MONTHS. INTERROGATION OF THE DEVICE REVEALED A HIGH BATTERY IMPEDANCE. PREMATURE DEPLETION IS SUSPECTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL TO AWAIT REPLACEMENT. WHILE IN THE HOSPITAL FOR 5 DAYS THE PATIENT EXPIRED. NO ALLEGATIONS OF DEVICE INVOLVEMENT THE DEATH HAVE BEEN MADE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT YET MADE AVAILABLE. IT WAS FURTHER REPORTED THAT THE VENTRICULAR LEAD HAD LOW IMPEDANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF "PRESYNCOPE SYMPTOMS." IT WAS FOUND THAT THE PATIENT'S DEVICE HAD BEEN AT THE ELECTIVE REPLACEMENT TIME FOR (B)(6). INTERROGATION OF THE DEVICE REVEALED A HIGH BATTERY IMPEDANCE. PREMATURE DEPLETION IS SUSPECTED. THE PATIENT WAS ADMITTED TO THE HOSPITAL TO AWAIT REPLACEMENT. WHILE IN THE HOSPITAL FOR (B)(6) THE PATIENT EXPIRED. NO ALLEGATIONS OF DEVICE INVOLVEMENT THE DEATH HAVE BEEN MADE. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT YET MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Death| H| L| R