BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2952091 · Received February 9, 2013

    Report

    Report Number
    2182208-2013-00121
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 8, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. PRODUCT EVALUATION SUMMARY: THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE ANDHAVE ANALYZED THE DATA. ANALYSIS REVEALED THERE WAS OVERSENSING WITH THE SHORT V-V INTERVAL OF LESS THAN 220 MILLISECONDS WITH 6 EPISODES OF VENTRICULAR FIBRILLATION AND 10 EPISODES OF NON-SUSTAINED VENTRICULAR TACHYCARDIA NOTED IN THE SAVE TO DISK ON (B)(6) 2012. THERE WAS ALSO INTERFERENCE/NOISE WITH MOST OF THE VENTRICULAR SHORT INTERVAL COUNTS INCLUDED IN THE LIFETIME COUNT OF 1363 OCCUR BEGINNING (B)(6) 2012. ADDITIONALLY, THERE WAS HIGH RESISTANCE/IMPEDANCE WITH RV PACE LEAD IMPEDANCE RISES FROM A BASELINE OF APPROXIMATELY 400 OHMS ON (B)(6) 2012 TO 1264 OHMS ON (B)(6) 2012. CONCOMITANT PRODUCT: 5076 IMPLANTABLE PACING LEAD, (B)(6) 2002. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS FROM THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD HAD AN APPARENT FRACTURE, OVERSENSING AND AN IMPEDANCE INCREASE WAS SEEN. THE RV LEAD WAS CAPPED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEENREPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56125 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS RICE CREEK MFG 694775

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR Hospitalization| L| R D154AWG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR