BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC.SIGMA

    MDR report key: 2952977 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00164
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    February 15, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. PRELIMINARY ANALYSIS REVEALED NO OUTPUT AND NO TELEMETRY. FURTHER TEST ING REVEALED THAT THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CLINIC VISIT THE PATIENT WAS IN ATRIAL FIBRILLATION OF APPROXIMATELY 45 BEATS PER MINUTE (BPM). ADDITIONALLY, THE DEVICE HAD NO PACING OUTPUT AND COULDN'T BE INTERROGATED. IT WAS ALSO REPORTED THAT THE DEVICE DEPLETED OUTSIDE OF ESTIMATED LONGEVITY AND POTENTIALLY PUT THE PATIENT AT RISK. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55839 MEDTRONIC.SIGMA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SSR303

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Hospitalization| R 4092 IMPLANTABLE PACING LEAD