BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONYX VR

    MDR report key: 1794384 · Received August 11, 2010

    Report

    Report Number
    6000094-2010-01519
    Event Type
    Injury
    Date Received
    August 11, 2010
    Date of Event
    May 17, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S40
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. THE PATIENTS WIFE ALSO REPORTED THAT A PHYSICIAN CONFIRMED THE LEAD HAD FRACTURED. "MY HUSBAND HAS INCURRED SEVERE ANXIETY AND DEPRESSION". NO FURTHER COMPLICATIONS (PATIENT AND SON) HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE RV LEAD IMPEDANCE ALERT TRIGGERED FOR IMPEDANCE > 2000 OHMS AND THERE WERE 223764 SINGLE PVCS AND 1281 PVC RUNS SINCE MAY 13TH. THE PATIENT RECEIVED 7 SHOCKS FOR WHAT CLINICIANS DEEMED TO BE OVERSENSING. THERE WERE MULTIPLE NST EPISODES < 220MS. THE PATIENT'S WIFE STATED "HIS DEVICE WENT OFF 4 TIMES BEFORE THE AMBULANCE ARRIVED AND THEN ANOTHER 2 TIMES IN THE AMBULANCE. WE WERE TOLD THAT IT WASN'T RELATED TO HIS HEART, THAT HIS HEART WAS FINE." PATIENTS WIFE FURTHER REPORTED THE PATIENT HAD BEEN OUT IN FIELD/SHOCKED WHILE SWEEPING AROUND AN OUTLET - LIGHT HEADED INTERMITTENTLY SINCE. PATIENT AND WIFE CONCERNED DEVICE WAS NOT FUNCTIONING AS IT SHOULD BE. PATIENTS WIFE STATED "MY HUSBANDS DEVICE SHOCKED HIM 6 TO 7 TIMES, MY SON ALSO GOT HURT BECAUSE HE WAS HOLDING ON TO HIS DAD. MY SONS FILLINGS IN HIS TEETH GOT HOT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONYX VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC S.A. 7290CX ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention