BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 200 DR

    MDR report key: 3990144 · Received August 7, 2014

    Report

    Report Number
    2647346-2014-00063
    Event Type
    Injury
    Date Received
    August 7, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Removal / Correction Number
    Z-1516-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 5076-58 LEAD, IMPLANTED: (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A PREVIOUS DEVICE CHECK, THE PATIENT WAS TOLD THAT THE DEVICE BATTERY WAS LOW AND NEEDED TO BE CHANGED OUT; HOWEVER, ACCORDING TO THE PATIENT¿S CHART, THE PATIENT WAS NOT SEEN AGAIN UNTIL THE PATIENT BECAME SYMPTOMATIC WITH BRADYCARDIA AND DIZZINESS. THE DEVICE BATTERY WAS DEAD. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465024 SIGMA 200 DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MDT PUERTO RICO OPERATIONS CO, MED REL SDR203B

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R 4568-45 LEAD