BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 1925290 · Received December 14, 2010

    Report

    Report Number
    6000144-2010-06275
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    October 6, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STATED THEY WERE HAVING BREATHING PROBLEMS ONE DAY POST IMPLANT AND WERE "GOING SLOW AND WANTED TO GO AT FULL." IT WAS REPORTED THAT DAYS LATER THE PATIENT WENT TO THE EMERGENCY ROOM WITH THEIR STITCHES OPEN AND THEIR WIRES HANGING OUT. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE PATIENT WAS TREATED FOR POTENTIAL INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDRS1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R 4076 X2 IMPLANTABLE PACING LEAD