BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXTEND

    MDR report key: 3053354 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04724
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 19, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE CLINIC RN THAT THIS PATIENT HAD A SIGNIFICANT HISTORY OF HEART FAILURE. THE CAUSE OF DEATH WAS ATTRIBUTED TO MULTI-ORGAN FAILURE AND WAS NOT DEVICE RELATED. THE PHYSICIAN WAS AWARE OF KNOWN RA LEAD ISSUES AND DUE TO THE PATIENT'S CONDITION NO RA LEAD REPLACEMENT WAS PLANNED. UPON HOSPITALIZATION IN (B)(6) 2013, THE PATIENT DID RECEIVE MULTIPLE SHOCK THERAPIES OF ATRIAL ARRHYTHMIAS. SOME RA OVERSENSING AND UNDERSENSING WAS IDENTIFIED. DURING A DEVICE FOLLOW-UP, COMPLETE UNDERSENSING OF THE RA WAS NOTED ASSOCIATED WITH NO RA CAPTURE. THE PHYSICIAN DECIDED TO REPROGRAM BI-VENTRICULAR OFF. FOLLOWING REPROGRAMMING OF THE DEVICE, THE PATIENT HAD A SINUS RATE AROUND 80 BPM WITH A NARROW QRS MORPHOLOGY. THE DEVICE WAS THEN REPROGRAMMED TO VVI 40. SOME CHANGES IN TACHYCARDIA DETECTION WERE ALSO UNDERTAKEN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. IT WAS NOT FELT THAT THE INAPPROPRIATE SHOCK CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THERE WERE NO ALLEGATIONS OR COMPLAINTS AGAINST THE DEVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A FAMILY MEMBER THAT THIS PATIENT HAD DIED IN (B)(6) 2013. THE FAMILY MEMBER COMMENTED THAT A COUPLE OF WEEKS PRIOR TO THE PATIENT'S DEATH, THE DEVICE DELIVERED MULTIPLE SHOCK THERAPIES THAT WERE NOT REQUIRED. ON ONE SUCH OCCASION, THE DEVICE DELIVERED FIVE INAPPROPRIATE SHOCKS. IT APPEARS THAT THE FAMILY MEMBER FELT THAT A DEVICE MALFUNCTION MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. ACCORDING TO THE FAMILY MEMBER, THE DEVICE WAS NOT EXPLANTED AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY TESTING. BOSTON SCIENTIFIC'S TECHNICAL SERVICES REVIEWED DATA STORED IN THIS PATIENT'S MONITORING SYSTEM. A REVIEW OF THE STORED DATA FOUND THAT ALL CHAMBER PACING IMPEDANCES WERE WITHIN NORMAL LIMITS. THE RV AND LV INTRINSIC AMPLITUDES WERE NORMAL. THE LAST RECORDED P-WAVE WAS 0.6 MV (9 DAYS PRIOR TO THIS PATIENT'S DEATH). THE RV AND LV PACING THRESHOLDS WERE 3.5 VOLTS AT 0.4 MS AND 3.5 VOLTS AT 0.8 MS RESPECTIVELY. THE RECORDED RA PACING THRESHOLD WAS 5 VOLTS AT 2.0 MS. THERE WAS EVIDENCE OF BOTH RA UNDERSENSING AND OVERSENSING. A REVIEW OF ONE OF THE STORED EPISODES SHOWS 1:1 TACHYCARDIA (SVT). THERE IS EVIDENCE OF ATRIAL UNDERSENSING AND FAR-FIELD R-WAVE SIGNALS ON THE RA CHANNEL THAT ARE NOT SENSED. FOR THIS EPISODE THE PATIENT RECEIVED ANTITACHYCARDIA PACING AND EXHAUSTS ALL SHOCKS IN THE VT ZONE (SIX TOTAL). THE RECORDED SHOCK IMPEDANCE VALUES RECORDED FOLLOWING SHOCK THERAPY WERE NORMAL (35-36 OHMS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154951 FLEXTEND IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4086

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR N141| H210| 4086| 4542| 0157| H217