BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 1921108 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05692
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A "HOT/PULSING SENSATION" IN HER ABDOMEN THE PATIENT ALSO STATED SHE "STILL HAS MISSED BEATS EVEN WITH THE PACEMAKER." IT WAS ALSO REPORTED THAT THE DEVICE WAS REPROGRAMMED THREE TIMES IN THE FIRST SIX WEEKS IT WAS IMPLANTED. IT WAS FURTHER REPORTED THAT THE PULSING SYMPTOMS HAD RECURRED AGAIN A YEAR LATER. THE PATIENT STATED WHEN THEY ARE ACTIVE THEY DO NOT FEEL IT. FOLLOWUP INDICATED THAT THE PATIENT REPORTED FEELING BETTER AND DECIDED NOT TO SEE THE DOCTOR RIGHT AWAY. THE DEVICE REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT REPORTED A "HOT/PULSING SENSATION" IN HER ABDOMEN THE PATIENT ALSO STATED SHE "STILL HAS MISSED BEATS EVEN WITH THE PACEMAKER". THE DEVICE REMAINS IMPLANTED. 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. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other| R 5076 (X2) IMPLANTABLE PACING LEAD| 5076 (X2) IMPLANTABLE PACING LEAD