BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1923264 · Received December 13, 2010

    Report

    Report Number
    2182208-2010-00968
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    October 12, 2010
    Report Date
    June 23, 2016
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S12
    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.

    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: (V)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. 2 - VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) <=210 MS AVERAGE V-CYCLE ON (B)(6) 2010 16:12:59 AND (B)(6) 2010 16:55:54. VENTRICULAR SHORT INTERVAL COUNT V-SIC=16.3 COUNTS AVG/DAY, IN 51.12 DAYS, BETWEEN (B)(6) 2010 09:08:18 AND (B)(6) 2010 12:04:33.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ADDR01, IMPLANTED: (B)(6) 2009; 5068-4, 5068-45, IMPLANTED: (B)(6) 1997. PRODUCT EVENT SUMMARY: THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE REPLACEMENT, THE RIGHT VENTRICLE LEAD INDICATED NOISE, HIGH IMPEDANCE AND APPARENT FRACTURE ON THE SUPERIOR VENA CAVA (SVC) COIL. THE SVC PIN WAS CAPPED, AND THE LEAD IS STILL IN USE WITH A SINGLE COIL CONFIGURATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE REPLACEMENT, THE RIGHT VENTRICLE LEAD INDICATED NOISE, HIGH IMPEDANCE AND APPARENT FRACTURE ON THE SUPERIOR VENA CAVA (SVC) COIL. THE SVC PIN WAS CAPPED, AND THE LEAD IS STILL IN USE WITH A SINGLE COIL CONFIGURATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED A FALL FROM THEIR MOTORCYCLE AND SUSTAINED TRAUMA. IT WAS ALSO REPORTED THAT THERE WAS OVERSENSING, NOISE AND A LEAD INTEGRITY ALERT TRIPPED ON THE VENTRICULAR LEAD. THE LEAD REMAINS IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE REPLACEMENT, THE RIGHT VENTRICLE LEAD INDICATED NOISE, HIGH IMPEDANCE AND APPARENT FRACTURE ON THE SUPERIOR VENA CAVA (SVC) COIL. THE SVC PIN WAS CAPPED, AND THE LEAD IS STILL IN USE WITH A SINGLE COIL CONFIGURATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT EXPERIENCED A FALL FROM THEIR MOTORCYCLE AND SUSTAINED TRAUMA. IT WAS ALSO REPORTED THAT THERE WAS OVERSENSING, NOISE AND A LEAD INTEGRITY ALERT TRIPPED ON THE VENTRICULAR LEAD. THE LEAD REMAINS IN USE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD WAS PARTIALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6942 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| R D284VRC IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5068X2 IMPLANTABLE PACING LEAD| ADDR01 IMPLANTABLE PACEMAKER| ADDR01 IMPLANTABLE PACEMAKER| 5068X2 IMPLANTABLE PACING LEAD| 7227CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 7227CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5068 X2 IMPLANTABLE PACING LEADS| ADDR01 IMPLANTABLE PACEMAKER