BEUDAMED
    FDA Adverse Event Death Summary report: N

    SILVERTRACE

    MDR report key: 6331891 · Received February 15, 2017

    Report

    Report Number
    8020045-2017-00006
    Event Type
    Death
    Date Received
    February 15, 2017
    Date of Event
    January 11, 2017
    Report Date
    April 10, 2017
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    PMA / PMN Number
    K024247
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NEITHER A LOT NUMBER NOR SAMPLES HAVE BEEN MADE AVAILABLE TO US, NO ANALYSES COULD BE PERFORMED. WE WERE REQUESTING MORE ON THE NATURE OF THE PROCEDURE, THE FOREIGN MATERIAL AND PHOTOS OF THE FOREIGN MATERIAL BUT WERE TOLD THIS WAS IMPOSSIBLE: "WE CANNOT CONTACT THE DOCTOR DUE TO DIE OF PATIENT. NO PHOTO". FURTHER ON IT WAS REPORTED: "THE DOCTOR DON'T KNOW WHETHER THE FM IS ECG GEL OR NOT. IN ADDITION, WHETHER THE PATIENT SWALLOWED AN EKG ELECTRODE OR NOT. THE DOCTOR GUESS IT. THE PATIENT WAS (B)(6), FEMALE. SHE MIGHT BE HUNGRY. BECAUSE (B)(6) 2017 SHE STARTED TO OFF-FOOD TREATMENT." BASED ON THE INFORMATION PROVIDED WE DO NOT KNOW WHETHER AN ELECTRODE OR A PART OF IT WAS ACTUALLY INGESTED BY THE PATIENT OR NOT. IT IS ALSO NOT CLEAR WHETHER ANY ALLEGATION EXISTS CONNECTING THE SUPPOSED INGESTION TO EITHER THE DEVELOPMENT OF PNEUMONIA OR THE DEATH OF THE PATIENT. TO CONDUCT ANY FURTHER ANALYSIS INFORMATION ABOUT THE NATURE OF THE FOREIGN MATERIAL REMOVED FROM THE STOMACH OF THE PATIENT IS REQUIRED. WE ARE CONTINUING TO REQUEST THIS INFORMATION FROM OUR SUPPLIER AND WILL ISSUE A FOLLOW-UP REPORT ONCE WE RECEIVE IT.

    Additional Manufacturer Narrative · 1

    AS NEITHER A LOT NUMBER NOR SAMPLES HAVE BEEN MADE AVAILABLE TO US, NO ANALYSES COULD BE PERFORMED. WE WERE REQUESTING MORE INFORMATION ON THE NATURE OF THE PROCEDURE, THE FOREIGN MATERIAL AND PHOTOS OF THE FOREIGN MATERIAL BUT WERE TOLD THIS WAS IMPOSSIBLE: "WE CANNOT CONTACT THE DOCTOR DUE TO DIE OF PATIENT. NO PHOTO". FURTHER ON IT WAS REPORTED: "THE DOCTOR DON'T KNOW WHETHER THE FM IS ECG GEL OR NOT. IN ADDITION, WHETHER THE PATIENT SWALLOWED AN EKG ELECTRODE OR NOT. THE DOCTOR GUESS IT. THE PATIENT WAS (B)(6), FEMALE. SHE MIGHT BE HUNGRY. BECAUSE (B)(6) 2017 SHE STARTED TO OFF-FOOD TREATMENT." BASED ON THE INFORMATION PROVIDED WE DO NOT KNOW WHETHER AN ELECTRODE OR A PART OF IT WAS ACTUALLY INGESTED BY THE PATIENT OR NOT. IT IS ALSO NOT CLEAR WHETHER ANY ALLEGATION EXISTS CONNECTING THE SUPPOSED INGESTION TO EITHER THE DEVELOPMENT OF PNEUMONIA OR THE DEATH OF THE PATIENT. WE RECEIVED ADDITIONAL INFORMATION ON OUR REQUESTS UNTIL 04/06/2017: - REQUEST FOR A PHOTO OF THE SWALLOWED PART: IT WAS MENTIONED IN THE REPORT THAT THE DOCTOR HAD REMOVED THE FM FROM HER STOMACH. THE CUSTOMER REPLIED: "SORRY. WE CANNOT CONTACT THE DOCTOR DUE TO DEATH OF PATIENT. NO PHOTO." - REQUEST FOR THE X-RAY IMAGE ON WHICH THE "SHADOW" IS VISIBLE: IT WAS MENTIONED IN THE REPORT, THAT THE PATIENT RECEIVED X-RAY. IN HER STOMACH, THERE WAS A SHADOW OF 10 MM, 7 MM? THE CUSTOMER REPLIED: "YES BUT NOT AVAILABLE AS WE ARE UNABLE TO CONTACT THE DOCTOR" - LOT NUMBER?: THE CUSTOMER REPLIED: "UNKNOWN." - NATURE OF THE PROCEDURE: THE CUSTOMER REPLIED: "PRIMARY DISEASE: RENAL INSUFFICIENCY(DIALYSIS PATIENT) WE DON'T KNOW WHY WAS PERFORMED AN EKG ON THE PATIENT." AS NO FURTHER DETAILS HAVE BEEN MADE AVAILABLE DESPITE OF REPEATED REQUESTS WE ARE UNABLE TO CONDUCT ANY FURTHER ANALYSIS AS TO WHAT HAS CAUSED THE PATIENT'S DEATH. WE THEREFORE CLOSE THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON JANUARY 24TH, 2017, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES IN (B)(6). MONITORING ECG ELECTRODES MODEL SKINTACT F-REC HAVE BEEN USED. THE INITIAL REPORT TO OUR DISTRIBUTOR STATED "THE CUSTOMER REPORTED THAT IT WAS POSSIBLE FOR THE PATIENT TO SWALLOW THE ECG. WE DON¿T KNOW WHETHER THE INJURY OR MEDICAL INTERVENTION IS REQUIRED OR NOT. THE CUSTOMER REQUESTED US ABOUT THE IMPACT OF HEALTH HAZARD." THEY THEN RECEIVED FURTHER INFORMATION FROM THEIR CUSTOMER IN (B)(6): "PRIMARY DISEASE: RENAL INSUFFICIENCY(DIALYSIS PATIENT). ON (B)(6) 2017: START TO OFF-FOOD TREATMENT. ON (B)(6) 2017: THE PATIENT CAUGHT PNEUMONIA. SHE RECEIVED X-RAY. IN THE STOMACH, THERE WAS A SHADOW OF 10 MM, 7 MM. ON (B)(6) 2017: THE DOCTOR USED THE GASTRIC CAMERA AND FOUND THE FM OF VISCOUS SECRETION IN HER STOMACH. IN ADDITION, THE DOCTOR REMOVED THE FM FROM HER STOMACH. (THE DOCTOR HAS THE FM). ON (B)(6) 2017: THE DOCTOR USED THE GASTRIC CAMERA AGAIN, BUT THERE WAS NOTHING. ON (B)(6) 2017: PATIENT HAS DIED" IT IS UNCLEAR WHETHER THE COMPLAINANT ALLEGES ANY CONNECTION BETWEEN THE ASSUMED INGESTION OF A PART OF AN ELECTRODE AND EITHER THE PNEUMONIA OR THE DEATH OF THE PATIENT. WE HAVE REQUESTED MORE INFORMATION FROM OUR DISTRIBUTOR, IN PARTICULAR MORE INFORMATION REGARDING THE NATURE OF THE FM REMOVED FROM THE STOMACH OF THE PATIENT ON (B)(6). THIS COMPLAINT WAS INITIALLY REPORTED BY (B)(4) BY CAREFUSION.

    Description of Event or Problem · 1

    ON JANUARY 24TH, 2017, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES IN (B)(6). MONITORING ECG ELECTRODES MODEL SKINTACT F-REC HAVE BEEN USED. THE INITIAL REPORT TO OUR DISTRIBUTOR STATED "THE CUSTOMER REPORTED THAT IT WAS POSSIBLE FOR THE PATIENT TO SWALLOW THE ECG. WE DON'T KNOW WHETHER THE INJURY OR MEDICAL INTERVENTION IS REQUIRED OR NOT. THE CUSTOMER REQUESTED US ABOUT THE IMPACT OF HEALTH HAZARD." THEY THEN RECEIVED FURTHER INFORMATION FROM THEIR CUSTOMER IN (B)(6): "PRIMARY DISEASE: RENAL INSUFFICIENCY(DIALYSIS PATIENT). ON (B)(6) 2017: START TO OFF-FOOD TREATMENT. ON (B)(6) 2017: THE PATIENT CAUGHT PNEUMONIA. SHE RECEIVED X-RAY. IN THE STOMACH, THERE WAS A SHADOW OF 10 MM, 7 MM. ON (B)(6) 2017: THE DOCTOR USED THE GASTRIC CAMERA AND FOUND THE FM OF VISCOUS SECRETION IN HER STOMACH. IN ADDITION, THE DOCTOR REMOVED THE FM FROM HER STOMACH. (THE DOCTOR HAS THE FM). ON (B)(6) 2017: THE DOCTOR USED THE GASTRIC CAMERA AGAIN, BUT THERE WAS NOTHING. (ON B)(6) 2017: PATIENT HAS DIED". IT IS UNCLEAR WHETHER THE COMPLAINANT ALLEGES ANY CONNECTION BETWEEN THE ASSUMED INGESTION OF A PART OF AN ELECTRODE AND EITHER THE PNEUMONIA OR THE DEATH OF THE PATIENT. WE HAVE REQUESTED MORE INFORMATION FROM OUR DISTRIBUTOR, IN PARTICULAR MORE INFORMATION REGARDING THE NATURE OF THE FM REMOVED FROM THE STOMACH OF THE PATIENT ON 01/11. THIS COMPLAINT WAS INITIALLY REPORTED BY UF/IMPORTER REPORT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113685 SILVERTRACE ECG ELECTRODE DRX LEONHARD LANG GMBH F-REC UNKOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death| O