BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2371470 · Received December 14, 2011

    Report

    Report Number
    2649622-2011-17632
    Event Type
    Injury
    Date Received
    December 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    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 ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE: 2 - PATIENT ALERT FOR RV.PACE LEAD Z ON (B)(4) 2011 03:00:03 AND (B)(4) 2011 03:00:03. WEEKLY PACE LEAD IMPEDANCE LOG DATA SHOW VARIOUS SPIKE INCREASES FOR MAX V.PACE = 320 TO 2608 OHMS RANGE BETWEEN (B)(4) 2010 AND (B)(4) 2011.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4) EVALUATION SUMMARY: (B)(4) PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAS BEEN ANALYZED. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE: 2 - PATIENT ALERT FOR RV.PACE LEAD Z ON (B)(4) 2011 03:00:03 AND (B)(4) 2011 03:00:03. WEEKLY PACE LEAD IMPEDANCE LOG DATA SHOW VARIOUS SPIKE INCREASES FOR MAX V.PACE = 320 TO 2608 OHMS RANGE BETWEEN (B)(4) 2010 AND (B)(4) 2011. THE FULL LEAD WAS RETURNED IN SEGMENTS AND WAS ANALYZED. THE DISTAL CONDUCTOR WAS FOUND TO BE FRACTURED, AND BLOOD/BODY FLUID WAS FOUND ON SEVERAL CONDUCTORS (NOT OBSTRUCTED). THE OUTER TUBING OVERLAY WAS MELTED AND BREACHED CUT, AND EXHIBITED COSMETIC ENVIRONMENTAL STRESS CRACKING. THE OUTER INSULATION WAS TORN AND BREACHED CUT, AND EXHIBITED A COSMETIC DEPRESSION. BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM, AND THE HELIX/LOBE WAS DISTORTED/BENT. A WHITE SUBSTANCE WAS FOUND ON THE EXPOSED DEFIB COIL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT SOUNDED, AND THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH AND VARYING IMPEDANCES. THE LEAD APPARENTLY FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ALERT SOUNDED, AND THE RIGHT VENTRICULAR LEAD EXHIBITED HIGH AND VARYING IMPEDANCES. THE LEAD APPARENTLY FRACTURED. THE LEAD WILL BE 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 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD| 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB