BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 2812640 · Received October 31, 2012

    Report

    Report Number
    6000144-2012-05874
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    March 4, 2012
    Report Date
    May 13, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER 7 MONTHS OF SERVICE BECAUSE OF LOSS OF TELEMETRY. ANALYSIS BY THE SUBMITTER INITIALLY CONFIRMED THE NO TELEMETRY CONDITION. DURING FINAL ANALYSIS, TELEMETRY WAS FOUND TO BE OPERATIONAL. THE SAVE TO DISK DATA WAS REVIEWED AND THE DEVICE REPORTED THAT A POR HAD OCCURRED AND THE DEVICE WAS PACING AT 65PPM. THE DEVICE WAS OPENED AND THE BATTERY MEASURED 3.1V. NO ADDITIONAL ANALYSIS WAS PERFORMED. THE LOSS OF TELEMETRY AND UNKNOWN POR EVENT COULD NOT BE DUPLICATED IN THE PAL. THE DEVICE WAS SUBJECTED TO A BATTERY OF ELECTRICAL TESTING ALONG WITH TEMPERATURE STRESSING WITH NO ANOMALOUS BEHAVIOR NOTED. A VISUAL INSPECTION OF THE EXPOSED COPPER TRACES ALONG THE CRYSTAL SIDE OF THE SCSP (SMALL CHIP SCALE PACKAGE) (U10) REVEALED THE PRESENCE OF FOREIGN MATERIAL BETWEEN TRACES 28 (VREF) AND 29 (AVSS). A SCANNING ELECTRON MICROSCOPE (SEM) INSPECTION NOTED COPPER ANOMALIES BETWEEN THESE TWO TRACES. SIMULATIONS OF LEAKAGE PATHS FROM THE VREF NODE TO THE AVSS NODE IN THE HYBRID SYSTEM BREADBOARD WERE CONSISTENT WITH THE REPORTED FIELD FAILURE CONDITIONS IN THIS DEVICE.

    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

    PRODUCT EVENT SUMMARY EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED AND DEVICE FAILURE DISAPPEARED DURING ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED. MULTIPLE PROGRAMMERS WERE ATTEMPTED WITHOUT SUCCESS. A MAGNET WAS PLACED OVER THE DEVICE, AND THE LEAD INTEGRITY ALERT WAS NOT TRIGGERED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED. MULTIPLE PROGRAMMERS WERE ATTEMPTED WITHOUT SUCCESS. A MAGNET WAS PLACED OVER THE DEVICE, AND THE LEAD INTEGRITY ALERT WAS NOT TRIGGERED. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE INTERROGATED. MULTIPLE PROGRAMMERS WERE ATTEMPTED WITHOUT SUCCESS. A MAGNET WAS PLACED OVER THE DEVICE, AND THE LEAD INTEGRITY ALERT WAS NOT TRIGGERED. 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
    1 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD