BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARELINK

    MDR report key: 2120857 · Received June 11, 2011

    Report

    Report Number
    3004593495-2011-00033
    Event Type
    Malfunction
    Date Received
    June 11, 2011
    Manufacturer
    PLEXUS MANUFACTURING SDN. BHD
    Product Code
    NVZ
    PMA / PMN Number
    P890003/S154
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE POWER UP TEST DID NOT FUNCTION WITH THE RETURNED POWER SUPPLY. THE POWER SUPPLY WAS OUT OF ELECTRICAL SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION: A CORRECTION TO MODEL NUMBER WAS MADE TO REFLECT CORRECT MODEL AS 2490C8. CORRECTING THE PHONE LINE CORRECTED THE ISSUE. NO INDICATION OF ANY REMOTE MONITOR FAILURE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CORRECTION: MODEL NUMBER WAS MADE TO REFLECT CORRECT MODEL AS 2490C8.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE HAS REPEATEDLY CALLED IN, BUT HAS NOT BEEN ABLE TO TRANSMIT. LAST SUCCESSFUL TRANSMISSION WAS A YEAR AGO. FURTHER REPORTED THERE HAD BEEN CHANGES MADE TO THE PHONE SERVICE. CHANGES WERE MADE BY THE PHONE COMPANY AND PATIENT TRANSMITTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE HAS REPEATEDLY CALLED IN, BUT HAS NOT BEEN ABLE TO TRANSMIT. LAST SUCCESSFUL TRANSMISSION WAS A YEAR AGO. FURTHER REPORTED THERE HAD BEEN CHANGES MADE TO THE PHONE SERVICE. CHANGES WERE MADE BY THE PHONE COMPANY AND PATIENT TRANSMITTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARELINK PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ PLEXUS MANUFACTURING SDN. BHD 2490C8 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6935 IMPLANTABLE TACHY LEAD| 6935 IMPLANTABLE TACHY LEAD| 6935 IMPLANTABLE TACHY LEAD