BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRUST

    MDR report key: 3991618 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14263
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Removal / Correction Number
    Z-1172-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: PRELIMINARY ANALYSIS FOUND THE DEVICE IN A NO-TELEMETRY CONDITION. FURTHER ANALYSIS FOUND THAT THE NO-TELEMETRY CONDITION WAS DUE TO A SEVERELY DEPLETED DEVICE BATTERY. WHEN POWERED WITH AN EXTERNAL SUPPLY, THE DEVICE FUNCTIONED NOMINALLY WITH REGARDS TO TELEMETRY AND PACING. FURTHER ANALYSIS WAS PERFORMED ON THE BATTERY CELL. TWO OPENINGS WERE FOUND IN THE TOP EDGE OF THE ANODE SEPARATOR ENCLOSURE IN SEGMENT 2 WITH LI (LITHIUM) MATERIAL PROTRUDING FROM THE OPENINGS. THE LI MATERIAL FROM ONE OF THE OPENINGS WAS TOUCHING THE EXPOSED CATHODE MATERIAL NEAR THE BASE OF THE CATHODE TAB. BASED ON THIS ANALYSIS, BATTERY DEPLETION WAS THE RESULT OF AN INTERNAL SHORT FROM THE DEPOSITED LI MATERIAL BREACHING THE ANODE SEPARATOR AND SUBSEQUENTLY CONTACTING THE CATHODE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS DEVICE WAS INCLUDED IN A FIELD ACTION. BASED ON THE INFORMATION RECEIVED AND WITHOUT THE RETURN OF EITHER THE PRODUCT OR PERFORMANCE DATA, OR COMPLETION OF ANALYSIS, IT COULD NOT BE DETERMINED IF THIS DEVICE PERFORMED AS DESCRIBED IN THE FIELD ACTION. (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 DEVICE REACHED RRT (RECOMMENDED REPLACEMENT TIME), HOWEVER THE PATIENT DID NOT HEAR AN ALERT UNTIL A FEW MONTHS LATER WHEN THE DEVICE EXPERIENCED CHARGE TIMEOUT. IT WAS ALSO REPORTED THAT THE DEVICE REACHED EOL (END OF LIFE) SOONER THAN 90 DAYS AFTER RRT. THE DEVICE 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
    471707 ENTRUST DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D154VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R 694958 LEAD