BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II VR

    MDR report key: 1854697 · Received October 5, 2010

    Report

    Report Number
    6000144-2010-04433
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    August 16, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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). PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS REVIEWED AND REVEALED INTERFERENCE/NOISE. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    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) PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS REVIEWED AND REVEALED INTERFERENCE/NOISE. HIGH V-SIC (SHORT INTERVAL COUNT) WAS OBSERVED WITH 90 COUNTS ON THE LIFETIME COUNTER, ALL OF THESE COUNTS OCCURRING ON (B)(4) 2010, THE DAY OF IMPLANT. HIGH SIC CAN INDICATE THE PRESENCE OF NOISE OR INTERMITTENCY IN THE SYSTEM. OVERSENSING WAS ALSO INDICATED. THREE SHORT V-V SENSED EVENTS OF < 220 MS OBSERVED ON (B)(4) 2010, THE DAY OF IMPLANT. (1 EPISODE NST, 2 EPISODES VF). DEVICE ANALYSIS REVEALED NO ANOMALIES. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE OUTER TUBING OVERLAY, THE OUTER TUBING OVERLAY WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT THE COMPLETION OF AN IMPLANT OF AN IMPLANTABLE DEFIBRILLATOR (ICD), THE HOSPITAL EXPERIENCED A MASSIVE POWER SURGE, INTERMITTENT POWER OUTAGE AND POSSIBLE BACKUP POWER BEING EMPLOYED. IT WAS THEN REPORTED THAT DURING THE POWER SURGE, THE PATIENT RECEIVED TWO SHOCKS FOR NO KNOWN REASON; THE ELECTROGRAM FROM THE ICD WAS CONSISTENT WITH NOISE; THE IMPLANTABLE SYSTEM WAS FULLY EVALUATED INCLUDING OPENING THE ICD POCKET. IT WAS REPORTED THAT THE PHYSICIAN ELECTED TO REMOVE AND REPLACE THE ICD SYSTEM (DEVICE AND LEAD). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II VR ASKU LWS MEDTRONIC MED REL, INC. D284VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| L| R