BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSA DR

    MDR report key: 1923163 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-06063
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    May 11, 2009
    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
    OK, US
    Reporter Occupation
    PHYSICIAN

    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. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND INDICATED THAT A DIAGNOSTICS PROBLEM OCCURRED. A LOW SUPPLY CONDITION WITHIN THE RANDOM ACCESS MEMORY CAUSED INVALID DIAGNOSTICS DATA. DIAGNOSTIC INFORMATION IS CONSISTENT WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CLINICIAN GOT A MISSING REPORTS PAGE FROM THE CARELINK TRANSMISSION. IT WAS FURTHER REPORTED THAT THE P AND R WAVE VALUES WERE LISTED AS "???" AND AN "INVALID DATA" MESSAGE WAS IN THE CAPTURE MANAGEMENT TREND. 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 VERSA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. VEDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R 4068 IMPLANTABLE PACING LEAD| 4024 IMPLANTABLE PACING LEAD| 4068 IMPLANTABLE PACING LEAD| 4024 IMPLANTABLE PACING LEAD