BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1991603 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02447
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. DAILY AND WEEKLY IMPEDANCE TRENDS ARE STEADY AND IN RANGE FOR THE RV PACE CIRCUIT. RV LEAD INTEGRITY WARNING ON (B)(6) 2010. 15 SHORT V-V CYCLE EPISODES (<220MS PERIOD) NOTED ON (B)(6) 2010. BETWEEN (B)(6) 2010 THERE WERE 265 V-SICS (SHORT INTERVAL COUNT) (AVE 34.8 V-SIC/DAY). IN THE DAY PRIOR TO THIS SESSION, THERE WAS ON AVE 111 V-SIC/DAY.

    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 DEFIBRILLATOR DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED 3 - PATIENT ALERTS FOR LEAD FAILURE PREDICTOR BETWEEN (B)(6) 2010 23:35:34 AND (B)(6) 2010 18:28:33. THERE WERE 15 - VENTRICULAR NST<=210 MS AVERAGE V-CYCLE ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 11:10:17 AND 11:27:21. THERE WAS 15 - VF<=190 MS AVERAGE V-CYCLE ON (B)(6) 2011 IN THE TIMEFRAME BETWEEN 10:28:09 AND 11:13:48. VENTRICULAR SHORT INTERVAL COUNT V-SIC=341.7 COUNTS AVG/DAY, IN 196.94 DAYS, BETWEEN (B)(6) 2010 14:15:03 AND (B)(6) 2011 12:55:19. BATTERY VOLTAGE - BATTERY DEPLETION INDICATED/ERI. SAVE TO DISK DATA SHOWS LAST CHARGE=21.41 SEC, DEVICE END OF SERVICE(EOS) > 16 SECOND CHARGE TIME AT (B)(6) 2011 11:15:40. THERE WAS 1 - PATIENT ALERT FOR EXCESSIVE CHARGE TIME ON (B)(6) 2011 11:15:15. THE LAST BATTERY MEASUREMENT= 2.6945 VOLTS ON (B)(6) 2011 13:09:29. (B)(4): THE FULL 5076 LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION WAS BREACHED FROM A CLAVICLE-RIB CRUSH. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM (SLEEVE HEAD) AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM. (B)(4): THE PARTIAL 6943 LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS TORN, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE TWO LEADS ARE IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY: (B)(4) THE DEFIBRILLATOR DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. DAILY AND WEEKLY IMPEDANCE TRENDS ARE STEADY AND IN RANGE FOR THE RV PACE CIRCUIT. RV LEAD INTEGRITY WARNING ON (B)(6) 2010. 15 SHORT V-V CYCLE EPISODES (<220MS PERIOD) NOTED ON B)(6) 2010. BETWEEN (B)(6) 2010 THERE WERE 265 V-SICS (SHORT INTERVAL COUNT) (AVE 34.8 V-SIC/DAY). IN THE DAY PRIOR TO THIS SESSION, THERE WAS ON AVE 111 V-SIC/DAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SHOCKED DUE TO OVERSENSING POSSIBLY CAUSED BY INTERFERENCE OR NOISE. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SHOCKED DUE TO OVERSENSING POSSIBLY CAUSED BY INTERFERENCE OR NOISE. IT WAS LATER REPORTED THAT THE DEVICE HAD REACHED THE END OF SERVICE DUE TO RIGHT VENTRICULAR (RV) LEAD FRACTURES AND MANY SHOCKS. THE RV LEAD AND DEVICE WERE EXPLANTED AND REPLACED. THE ACTIVE ATRIAL LEAD EXHIBITED NOISE AND WAS ALSO EXPLANTED AND REPLACED. NO FURTHER 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 PUERTO RICO, INC. 6943 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization| L| R 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5076 IMPLANTABLE PACING LEAD