BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TPW 24IN 2-0 D/A RB-1,SKS BWY

    MDR report key: 20040812 · Received August 22, 2024

    Report

    Report Number
    2210968-2024-08819
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    December 1, 2021
    Report Date
    October 23, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    LDF
    UDI-DI
    10705031050860
    PMA / PMN Number
    K980503
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H6 COMPONENT CODE: G07002 DEVICE NOT RETURNED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: IT WAS REPORTED THAT THE PACING WIRE SNAPPED DURING PACING. UNTIL REATTACHED. DID THE PACING WIRE DETACH FROM THE EXTERNAL PACE MAKER? NO, THE WIRE DID NOT DETACH FROM THE PACING BOX. OR DID THE PACING WIRE BREAK? THE PACING WIRE SNAPPED AT THE POINT WHERE THERE THE WIRE MEETS THE METAL PIN. THE EVENT STATED ¿INTERVENTION TO RE ATTACH THE PACING WIRE AS QUICKLY AS POSSIBLE¿. HOW WAS THE WIRE REATTACHED? PLEASE DESCRIBE AND PROVIDE DETAILS. AS THE PATIENT WAS DEPENDENT ON PACING, THE WIRE WAS STRIPPED OF THE PLASTIC COVERING TO EXPOSE THE METAL CORE WHICH WAS THEN INSERTED INTO THE PACING BOX TO ENABLE PACING TO BE RE-ESTABLISHED. WAS A SURGICAL PROCEDURE REQUIRED TO RE-ATTACH THE PACING WIRE? NO. WHAT WAS THE ROUTINE CARE BEING PERFORMED WHEN THE PACING WIRE SNAPPED? WASHING AND PROVIDING PRESSURE AREA CARE AND EYE AND MOUTH CARE. HOW LONG AFTER THE WIRE WAS INSERTED DID THE WIRE SNAP (HOW MANY HOURS/DAYS)? THE WIRES WERE INSERTED ON (B)(6) 2021 AND THE INCIDENT OCCURRED ON THE (B)(6) 2021 THE PROCEDURE AND EVENT DATE WERE REPORTED AS (B)(6) 2021. IS THIS CORRECT? THE WIRES WERE INSERTED ON (B)(6) 2021 AND THE INCIDENT OCCURRED ON THE (B)(6) 2021 CURRENT CONDITION OF THE PATIENT? THE PATIENT WAS DISCHARGED FOLLOWING THIS EPISODE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. LOT RGBB2B IS INVALID. PLEASE PROVIDE THE CORRECT LOT NUMBER.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 10/23/2024. A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED, AND NO RELATED NON-CONFORMANCES WERE IDENTIFIED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). DATE SENT TO THE FDA: 9/24/2024. ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: I HAVE BEEN ABLE TO REVIEW THE PATIENT NOTES AND THERE WAS AN ERROR WHEN I DOCUMENTED THE BATCH NUMBER OF THE PRODUCT. THE BATCH NUMBER RECORDED IN THE THEATRE NOTES IS RGBBZB THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2021 AND A TEMPORARY PACING WIRE WAS PLACED. DURING ROUTINE CARE ON (B)(6) 2021, THE PACING WIRE SNAPPED DURING PACING AT THE POINT WHERE THERE THE WIRE MEETS THE METAL PIN, WHICH RESULTED IN NO PACING FOR PERIOD OF TIME UNTIL REATTACHED. THE WIRE WAS RE-ATTACHED AS QUICKLY AS POSSIBLE. THE WIRE WAS STRIPPED OF THE PLASTIC COVERING TO EXPOSE THE METAL CORE WHICH WAS THEN INSERTED INTO THE PACING BOX TO ENABLE PACING TO BE RE-ESTABLISHED. AN ALTERNATIVE SUPPLIER OF PACING WIRE WAS USED. THERE WAS NO OBVIOUS REASON FOR THE WIRE TO SNAP. THERE WAS NO PATIENT HARM, HOWEVER LOTS OF STRESS AND ANXIETY FOR ALL CONCERNED, BUT NO INJURY TO PATIENT. THE PATIENT WAS DISCHARGED FOLLOWING THIS EPISODE. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527952 TPW 24IN 2-0 D/A RB-1,SKS BWY ELECTRODE, PACEMAKER, TEMP LDF ETHICON INC. RGBBZB 10705031050860

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown