BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT DR

    MDR report key: 3062170 · Received April 16, 2013

    Report

    Report Number
    3004209178-2013-06397
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    December 1, 2012
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED SHORTING/LOW IMPEDANCE IN THE HYBRID.

    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: 7122 COMPETITOR IMPLANTABLE TACHY LEAD 2012 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED TO THE CLINIC, THE PHYSICIAN WAS UNABLE TO INTERROGATE THE DEVICE. THE PATIENT WAS THEN SENT TO THE ER (EMERGENCY ROOM). THE DEVICE WAS EXPLANTED AND REPLACED. HOWEVER; UPON THE EXPLANT OF THE DEVICE, IT WAS NOTICED THAT THE SVC (SUPERIOR VENA CAVA) PORT DID NOT HAVE A PLUG IN IT AS THE PATIENT HAD A SINGLE COIL LEAD. IT WAS ALSO NOTED THAT THE PATIENT MENTIONED A BURNING SENSATION AROUND THE DEVICE IN (B)(6) AND HAD GONE TO THE ER, BUT THE DEVICE WAS NOT INTERROGATED THEN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162966 PROTECTA XT DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO D314DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD