BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2451832 · Received February 14, 2012

    Report

    Report Number
    2182208-2012-00137
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    November 22, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. UPON FURTHER REVIEW, THIS MDR WAS NOT A REPORTABLE MALFUNCTION AND MDR REPORT 2182208000201200137 IS BEING REDACTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THE E-DEVICE CELLULAR ACCESSORY HAD THE RED LIGHT BLINKING DURING A NON-TRANSMISSION. THE ACCESSORY WAS UNPLUGGED AND RELOCATED, THE ANTENNAE WAS ADJUSTED AND THE SUBSCRIBER IDENTIFICATION MODULE (SIM) CARD WAS REMOVED AND REINSERTED BUT THE SITUATION DID NOT RESOLVE. THE ACCESSORY WAS RETURNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE E-DEVICE CELLULAR ACCESSORY HAS ITS RED LIGHT "BLINKING" DURING A NON-TRANSMISSION ACTIVITY. THE ACCESSORY HAS TRANSMITTED PREVIOUSLY. TROUBLESHOOTING STEPS WERE TAKEN. THE ACCESSORY WILL BE RETURNED. THE MONITOR ASSOCIATED WITH THIS ACCESSORY WILL REMAIN IN USE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PATIENT MONITORING ACCESSORY NVZ MEDTRONIC, INC. MLINK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD| 6947 IMPLANTABLE TACHY LEAD| 4396 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4396 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD