BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADAPTA DR

    MDR report key: 1962655 · Received January 18, 2011

    Report

    Report Number
    2647346-2011-00024
    Event Type
    Death
    Date Received
    January 18, 2011
    Date of Event
    December 26, 2009
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND. (B)(4), PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. ALL CONDUCTORS WERE STRETCHED, AND THERE WAS APPARENT EXPLANT DAMAGE. VISUAL ANALYSIS WAS PERFORMED. (B)(4), PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. ALL CONDUCTORS WERE STRETCHED, AND THERE WAS APPARENT EXPLANT DAMAGE. VISUAL WAS ANALYSIS PERFORMED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND. (B)(4), PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. ALL CONDUCTORS WERE STRETCHED, AND THERE WAS APPARENT EXPLANT DAMAGE. VISUAL ANALYSIS WAS PERFORMED ONLY. (B)(4), PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. ALL CONDUCTORS WERE STRETCHED, AND THERE WAS APPARENT EXPLANT DAMAGE. VISUAL WAS ANALYSIS PERFORMED ONLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY THREE MONTHS POST SYSTEM IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY THREE MONTHS POST SYSTEM IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. BASED ON FOLLOW-UP RECEIVED, THE PATIENT WAS SEEN FOR A PACEMAKER CHECK APPROXIMATELY THREE MONTHS PRIOR TO THE PATIENT'S DEATH. THE PACEMAKER WAS FUNCTIONING NORMALLY. THE PATIENT LATER DIED IN HOSPICE CARE. THE CAUSE OF DEATH WAS RENAL FAILURE, NEPHROSCLEROSIS, AND HYPERTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDRL1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death