BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GENERATOR, PERMANENT, IMPLANTABLE

    MDR report key: 3991262 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02167
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 4, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    NVZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: CARDIAC IMPLANTABLE ELECTRONIC DEVICE REUTILIZATION: BATTERY LIFE OF EXPLANTED DEVICES AT A TERTIARY CARE CENTER. PACE PACING AND CLINICAL ELECTROPHYSIOLOGY. 2014;37(5):569-575. AN EMAIL WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AS OF YET. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THESE IMPLANTABLE PULSE GENERATORS (IPG) AND IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICD). MULTIPLE PATIENTS AND MULTIPLE FAILURE MODES AND INFECTION WAS NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE LEAD/SERIAL NUMBERS. THE ARTICLE INCLUDED THE FOLLOWING FAILURE MODES: DEVICE FAILURE AND DEVICE RECALL. DURING A RETROSPECTIVE REVIEW OF EXPLANTED DEVICE FOR POTENTIAL RE-USE, IT WAS NOTED THAT MULTIPLE DEVICE WAS EXPLANTED DUE TO INFECTION, DEVICE FAILURE AND DEVICE RECALL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472796 PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ RICE CREEK MFG MDT-IPG

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R