BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 2288733 · Received October 12, 2011

    Report

    Report Number
    2182208-2011-02132
    Event Type
    Malfunction
    Date Received
    October 12, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S10
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 PARTIAL LEAD WAS RETURNED IN SEGMENTS AND NO ANOMALIES WERE FOUND. HOWEVER, IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS CUT TINES/LOBES, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, AND THERE WAS APPARENT EXPLANT DAMAGE. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. IMPEDANCE - HIGH RESISTANCE/IMPEDANCE 2 - PATIENT ALERTS FOR RV.PACE LEAD Z ON (B)(6) 2011. WEEKLY PACING LEAD IMPEDANCE LOG DATA SHOWS A GRADUAL INCREASE FOR MIN AND MAX V.PACE= 784 TO 1504 OHMS PEAK BETWEEN (B)(6) 2009 AND (B)(6) 2011. SENSING - OVERSENSING 1 - VENTRICULAR NST =210 MS ON (B)(6) 2010 19:10:39; 1 - VF=210 MS AVERAGE V-CYCLE ON (B)(6) 2010 19:10:45.

    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 DEVICE 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 ALERTS FOR RV. PACE LEAD Z ON 01-JUN-2011 AND 21-JUN-2011. WEEKLY PACING LEAD IMPEDANCE LOG DATA SHOWS A GRADUAL INCREASE FOR MIN AND MAX V. PACE= 784 TO 1504 OHMS PEAK BETWEEN 18-DEC-2009 AND 08-JUL-2011. SENSING - OVERSENSING 1 - VENTRICULAR NST =210 MS ON 02-OCT-2010 19:10:39. 1 - VF=210 MS AVERAGE V-CYCLE ON 02-OCT-2010 19:10:45.

    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 DEVICE 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 ALERTS FOR RV.PACE LEAD Z ON (B)(6) 2011. WEEKLY PACING LEAD IMPEDANCE LOG DATA SHOWS A GRADUAL INCREASE FOR MIN AND MAX V.PACE= 784 TO 1504 OHMS PEAK BETWEEN (B)(6) 2009 AND (B)(6) 2011. SENSING - OVERSENSING 1 - VENTRICULAR NST =210 MS ON (B)(6) 2010 19:10:39. 1 - VF=210 MS AVERAGE V-CYCLE ON (B)(6) 2010 19:10:45.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD SHOWS A SLOW RISE IN IMPEDANCE. THE LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE PACING THRESHOLDS ARE STEADILY RISING. 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 LEAD SHOWS A SLOW RISE IN IMPEDANCE. THE LEAD REMAINS IN USE. 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6932 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| O| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB