BEUDAMED
    FDA Adverse Event Death Summary report: N

    SCREW-IN

    MDR report key: 1811969 · Received August 24, 2010

    Report

    Report Number
    2649622-2010-08868
    Event Type
    Death
    Date Received
    August 24, 2010
    Date of Event
    June 12, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. LATER REPORTED THE PATIENT HAD EXPERIENCED HYPOTENSION SECONDARY TO PAIN MEDICATION POST SYSTEM MODIFICATION PROCEDURE TO PLACE THE LV (LEFT VENTRICULAR) LEAD. THE HYPOTENSION WAS TREATED WITH INTRAVENOUS FLUIDS AND DOBUTAMINE AND THE EVENT IS REPORTED TO HAVE RESOLVED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH LV THRESHOLDS ON (B)(6)2010. THE LV THRESHOLD INCREASED BY 2V FROM (B)(6)2010 TO (B)(6)2010. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED (B)(6)2010. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. FOLLOW UP REVEALED THE PATIENT WAS FOUND DOWN, SLUMPED OVER A CHAIR. EVENT UNWITNESSED AND NO HISTORY OF SYNCOPE. WHEN EMS ARRIVED, PATIENT WAS "APPARENTLY IN ASYSTOLE AS WELL AS PEA TYPE ARREST." CAUSE OF DEATH REPORTED AS ARRHYTHMIA, CARDIAC ARREST, RESPIRATORY ARREST, TRAUMATIC INJURY, OVERDOSE, ASPHYXIATION, RENAL FAILURE. DEVICE WAS NOT INTERROGATED, NOT KNOWN IF HE RECEIVED SHOCKS, AND DEVICE WAS NOT EXPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED LEAD HAD HIGH LV THRESHOLDS ON (B)(6) 2010. THE LV THRESHOLD INCREASED BY 2V FROM (B)(6) 2010 TO (B)(6) 2010. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED PATIENT DIED (B)(6) 2010. NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT DEATH WAS DEVICE RELATED. FOLLOW UP REVEALED PATIENT WAS DOWN APPROXIMATELY 15 MINUTES, SLUMPED OVER A CHAIR. EVENT UNWITNESSED AND NO HISTORY OF SYNCOPE. WHEN EMS ARRIVED, PATIENT WAS "APPARENTLY IN ASYSTOLE AS WELL AS PEA TYPE ARREST." CAUSE OF DEATH REPORTED AS ARRHYTHMIA, CARDIAC ARREST, RESPIRATORY ARREST, TRAUMATIC INJURY, OVERDOSE, ASPHYXIATION, RENAL FAILURE. DEVICE WAS NOT INTERROGATED, NOT KNOWN IF HE RECEIVED SHOCKS, AND DEVICE WAS NOT EXPLANTED. ADDITIONAL FOLLOW UP REVEALED THAT PRIOR TO THIS EVENT, PATIENT HAD BEEN FEELING "HIS STEADY USUAL SELF, BUT HAD BEEN FATIGUED." HE HAD NOT BEEN COMPLAINING OF ANY CHEST PAIN OR OVERT HEART FAILURE SYMPTOMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH LV THRESHOLDS ON (B)(6) 2010. THE LV THRESHOLD INCREASED BY 2V FROM (B)(6) 2010 TO (B)(6) 2010. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT DIED (B)(6) 2010. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED LEAD HAD HIGH LV THRESHOLDS ON (B)(6) 2010. THE LV THRESHOLD INCREASED BY 2V FROM (B)(6) 2010. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED PATIENT DIED (B)(6) 2010. NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT DEATH WAS DEVICE RELATED. FOLLOW UP REVEALED PATIENT WAS DOWN APPROXIMATELY 15 MINUTES, SLUMPED OVER A CHAIR. EVENT UNWITNESSED AND NO HISTORY OF SYNCOPE. WHEN EMS ARRIVED, PATIENT WAS "APPARENTLY IN ASYSTOLE AS WELL AS PEA TYPE ARREST." CAUSE OF DEATH REPORTED AS ARRHYTHMIA, CARDIAC ARREST, RESPIRATORY ARREST, TRAUMATIC INJURY, OVERDOSE, ASPHYXIATION, RENAL FAILURE. DEVICE WAS NOT INTERROGATED, NOT KNOWN IF HE RECEIVED SHOCKS, AND DEVICE WAS NOT EXPLANTED. ADDITIONAL FOLLOW UP REVEALED THAT PRIOR TO THIS EVENT, PATIENT HAD BEEN FEELING "HIS STEADY USUAL SELF, BUT HAD BEEN FATIGUED." HE HAD NOT BEEN COMPLAINING OF ANY CHEST PAIN OR OVERT HEART FAILURE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCREW-IN ASKU DTB MEDTRONIC PUERTO RICO, INC. 5071 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death| H| L| R 6935 IMPLANTABLE TACHY LEAD| 4076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4076 IMPLANTABLE PACING LEAD| 6935 IMPLANTABLE TACHY LEAD