BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC.SIGMA

    MDR report key: 2864969 · Received December 10, 2012

    Report

    Report Number
    9614453-2012-00259
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    October 19, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND THE WIREBOND WAS LOOSE/DETACHED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) PRODUCT PERFORMANCE INFORMATION WAS RECEIVED, ANALYZED, AND HIGH VENTRICULAR IMPEDANCE/RESISTANCE WAS NOTED. HIGH (OUT OF RANGE) IMPEDANCE ON VENTRICULAR LEAD OCCURRED ON (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US 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 VENTRICULAR LEAD HAD UNDEFINED IMPEDANCE AND A RISE IN THRESHOLD. UNDER FLUOROSCOPY, THE LEAD LOOKED "OK" AND NO FRACTURE WAS FOUND. A FEW DAYS LATER, THE LEAD WAS CAPPED AND REPLACED, AND 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 VENTRICULAR LEAD HAD UNDEFINED IMPEDANCE AND A RISE IN THRESHOLD. UNDER FLURORSCOPY, THE LEAD LOOKED "OK" AND NO FRACTURE WAS FOUND. A FEW DAYS LATER, THE LEAD WAS CAPPED AND REPLACED, AND 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 VENTRICULAR LEAD HAD UNDEFINED IMPEDANCE AND A RISE IN THRESHOLD. UNDER FLUOROSCOPY, THE LEAD LOOKED "OK" AND NO FRACTURE WAS FOUND. A FEW DAYS LATER, THE LEAD WAS CAPPED AND REPLACED, AND 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 MEDTRONIC.SIGMA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND SVDD303

    Patients

    Seq Age Sex Outcome Treatment
    1 00087 YR Hospitalization| R 5038 IMPLANTABLE PACING LEAD