BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECURA DR

    MDR report key: 2955264 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-01907
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    February 15, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-0115-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS 5076 IMPLANTABLE PACING LEAD (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 99 % OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE TIME OF RECOMMENDED REPLACEMENT TIME (RRT) WAS 2012 (B)(4). THE RRT VOLTAGE WAS LESS THAN OR EQUAL TO 2.625. THE WEEKLY BATTERY VOLTAGE TREND DATA SHOWED A MINIMUM BATTERY VOLTAGE OF 2.632 TO 2.618 VOLTS BETWEEN 2012 (B)(4) AND 2012 (B)(4). THERE WAS A LOW BATTERY ALERT ON 2012 (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  HAD EARLY BATTERY DEPLETION. THE ICD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59316 SECURA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6949 IMPLANTABLE TACHY LEAD