BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABLE BASE

    MDR report key: 8845443 · Received July 31, 2019

    Report

    Report Number
    8020045-2019-00018
    Event Type
    Injury
    Date Received
    July 31, 2019
    Report Date
    January 22, 2020
    Manufacturer
    LEONHARD LANG GMBH
    Product Code
    DRX
    UDI-DI
    10861779000274
    PMA / PMN Number
    K023503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLES OF THE 7 DIFFERENT LOT/BATCHES OF MODEL SBT601 [DI PORTION: (01)10861779000281 ] (170717-0257, 180221-0257, 180316-0259, 180322-0252, 180419-0158, 180420-0159, 180424-0151) AND 14 DIFFERENT LOT/BATCHES OF MODEL SBW601 [DI PORTION: (01)10861779000274] (170829-0165, 180416-0156, 180518-0073, 180522-0074, 180524-0075, 180525-0076, 180529-0077, 180604-0078, 190107-0257, 190110-0258, 190114-0259, 190116-0251, 190117-0252, 190213-0071) HAVE BEEN INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 4 RETAINED SAMPLES OF EACH LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. NO INFORMATION ON SKIN TYPE, STATE OF SKIN, WHETHER ANY MEDICATION WAS BEING TAKEN, WHICH MIGHT HAVE A SKIN WEAKENING EFFECT, AND HOW THE SKIN WAS PREPARED BEFORE APPLICATION OF THE ELECTRODES WAS PROVIDED. WE HAVE REQUESTED FURTHER INFORMATION ON EACH OF THE EVENTS. THE COMPLAINTS WERE GATHERED BY ONE TIER-3 DISTRIBUTORS OVER A PERIOD OF 3 MONTHS AND SUBMITTED TO OUR DISTRIBUTOR. THIS COMPLAINT HAS TO BEE SEEN IN CONNECTION TO TWO EARLIER COMPLAINTS ORIGINATING FROM THE SAME TIER-3 DISTRIBUTOR (REPORTED AS MDR 8020045- 2018-00026 AND MDR 8020045-2019-00007). WE GET 1-2 SKIN REACTION COMPLAINTS A MONTH IN AVERAGE FOR AN ANNUAL QUANTITY OF HALF A BILLION ELECTRODES SOLD. WE DO NOT HAVE ANY OTHER CASE OF A CUSTOMER WITH SUCH A NUMBER OF CASES OF SKIN REACTIONS. THE RECENTLY RECEIVED NUMBER OF CASES (53 FOR A PERIOD OF THREE MONTHS) FOR THIS TIER-3 DISTRIBUTOR INDICATES AN AGGREGATE OF UP TO 200 A YEAR FOR THEM. EVEN WHEN WE BREAK IT DOWN TO THE SPECIFIC MODELS LISTED IN THE COMPLAINTS, THE RATIO DOES NOT MAKE SENSE. WE HAVE MADE MORE THAN 20 MILLION OF MODELS T-601 AND W-601 IN 2018. 3,5 MILLION OF THESE WERE PRIVATE LABELED FOR A TIER-2 DISTRIBUTOR. WE DO NOT KNOW, HOW MANY OF THEM WENT ON TO THE TIER-3 DISTRIBUTOR. HOWEVER, EVEN IF THEY ALL DID, WE'D BE SEEING ALL CASES OF SKIN IRRITATION REPORTED ORIGINATING FROM ABOUT 17% OF THE TOTAL NUMBER OF PRODUCTS AND NONE IN 2018 FROM OTHER CUSTOMERS (REPRESENTING 83% OF THE PRODUCTS). WE THEREFORE ASSUME THAT AN ADDITIONAL PARAMETER OR CIRCUMSTANCES YET UNKNOWN ARE CAUSAL FOR THE INCREASED INCIDENCE OF SKIN IRRITATIONS. AS NO FURTHER INFORMATION WAS AVAILABLE DESPITE REPEATED REQUESTS FOR THE ALREADY EXISTING INCIDENTS WE HAVE DESIGNED A NEW QUESTIONNAIRE TAYLORED TO THE CUSTOMER'S SPECIAL USE MODEL. WITH THE NEW QUESTIONAIRE, WE ARE CONFIDENT TO RECEIVE IMPROVED INFORMATION ON FUTURE INCIDENTS TO BE ABLE TO DETERMINE A ROOT CAUSE. HOWEVER AS NO FURTHER INFORMATION WAS MADE AVAILBE ON THE INCIDENTS COVERED IN THIS REPORT, NO CONCLUSION CAN BE DRAWN WHAT MIGHT HAVE CAUSED THE CUSTOMERS PROBLEMS. WE CONSIDER THE INVESTIGATION CLOSED AND WILL ONLY RESUME IT WHEN NEW CASES ARE REPORTED. WE WOULD COVER THEM UNDER A NEW MDR.

    Description of Event or Problem · 0

    ON (B)(6) 2019, WE HAVE BEEN INFORMED ABOUT SEVERAL INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH A VERITY ECG MONITOR. THE INITIAL REPORT STATED THAT "PATIENTS REPORTED SEVERE SKIN IRRITATION WITH OPEN SORES AND/OR BLEEDING. THERE WERE 53 ACCOUNTS FROM (B)(6) 2019." THE REPORT REFERRED TO 53 SEPARATE CASES, INVOLVING A TOTAL OF 7 DIFFERENT LOT/BATCHES OF MODEL SBT601 AND 14 DIFFERENT LOT/BATCHES OF MODEL SBW601 . NO FURTHER INFORMATION WAS PROVIDED IF AND HOW THE INJURIES HAD TO BEEN TREATED AFTER THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    RETAINED SAMPLES OF THE 7 DIFFERENT LOT/BATCHES OF MODEL SBT601 [DI PORTION: (B)(4)] (170717-0257, 180221-0257, 180316-0259, 180322-0252, 180419-0158, 180420-0159, 180424-0151) AND 14 DIFFERENT LOT/BATCHES OF MODEL SBW601 [DI PORTION: (B)(4)] (170829-0165, 180416-0156, 180518-0073, 180522-0074, 180524-0075, 180525-0076, 180529-0077, 180604-0078, 190107-0257, 190110-0258, 190114-0259, 190116-0251, 190117-0252, 190213-0071) HAVE BEEN INSPECTED VISUALLY. MECHANICAL TESTS WERE PERFORMED ON 4 RETAINED SAMPLES OF EACH LOT NUMBER. ALL TESTED SAMPLES WERE FOUND TO PERFORM WITHIN LIMITS. NO FAULTS COULD BE DETECTED. NO INFORMATION ON SKIN TYPE, STATE OF SKIN, WHETHER ANY MEDICATION WAS BEING TAKEN, WHICH MIGHT HAVE A SKIN WEAKENING EFFECT, AND HOW THE SKIN WAS PREPARED BEFORE APPLICATION OF THE ELECTRODES WAS PROVIDED. WE HAVE REQUESTED FURTHER INFORMATION ON EACH OF THE EVENTS. THE COMPLAINTS WERE GATHERED BY ONE TIER-3 DISTRIBUTORS OVER A PERIOD OF 3 MONTHS AND SUBMITTED TO OUR DISTRIBUTOR. THIS COMPLAINT HAS TO BEE SEEN IN CONNECTION TO TWO EARLIER COMPLAINTS ORIGINATING FROM THE SAME TIER-3 DISTRIBUTOR (REPORTED AS MDR 8020045-2018-00026 AND MDR 8020045-2019-00007). WE GET 1-2 SKIN REACTION COMPLAINTS A MONTH IN AVERAGE FOR AN ANNUAL QUANTITY OF HALF A BILLION ELECTRODES SOLD. WE DO NOT HAVE ANY OTHER CASE OF A CUSTOMER WITH SUCH A NUMBER OF CASES OF SKIN REACTIONS. THE RECENTLY RECEIVED NUMBER OF CASES (53 FOR A PERIOD OF THREE MONTHS) FOR THIS TIER-3 DISTRIBUTOR INDICATES AN AGGREGATE OF UP TO 200 A YEAR FOR THEM. EVEN WHEN WE BREAK IT DOWN TO THE SPECIFIC MODELS LISTED IN THE COMPLAINTS, THE RATIO DOES NOT MAKE SENSE. WE HAVE MADE MORE THAN 20 MILLION OF MODELS T-601 AND W-601 IN 2018. 3,5 MILLION OF THESE WERE PRIVATE LABELED FOR A TIER-2 DISTRIBUTOR. WE DO NOT KNOW, HOW MANY OF THEM WENT ON TO THE TIER-3 DISTRIBUTOR. HOWEVER, EVEN IF THEY ALL DID, WE'D BE SEEING ALL CASES OF SKIN IRRITATION REPORTED ORIGINATING FROM ABOUT 17% OF THE TOTAL NUMBER OF PRODUCTS AND NONE IN 2018 FROM OTHER CUSTOMERS (REPRESENTING 83% OF THE PRODUCTS). WE THEREFORE ASSUME THAT AN ADDITIONAL PARAMETER OR CIRCUMSTANCES YET UNKNOWN ARE CAUSAL FOR THE INCREASED INCIDENCE OF SKIN IRRITATIONS. WE HAVE REQUESTED ADDITIONAL INFORMATION TO CONDUCT FURTHER INVESTIGATIONS AND WILL REPORT ANY FINDINGS IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ON JULY 15TH, 2019, WE HAVE BEEN INFORMED ABOUT SEVERAL INCIDENTS WITH ECG ELECTRODES. MONITORING ECG ELECTRODES (MODEL SBW601 AND SBT601) HAD BEEN USED WITH A VERITY ECG MONITOR. THE INITIAL REPORT STATED THAT "PATIENTS REPORTED SEVERE SKIN IRRITATION WITH OPEN SORES AND/OR BLEEDING. THERE WERE 53 ACCOUNTS FROM (B)(6) 2019 TO (B)(6) 2019." THE REPORT REFERRED TO 53 SEPARATE CASES, INVOLVING A TOTAL OF 7 DIFFERENT LOT/BATCHES OF MODEL SBT601 AND 14 DIFFERENT LOT/BATCHES OF MODEL SBW601 . NO FURTHER INFORMATION WAS PROVIDED IF AND HOW THE INJURIES HAD TO BEEN TREATED AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642953 STABLE BASE ECG ELECTRODE DRX LEONHARD LANG GMBH W-601 190213-0071 10861779000274

    Patients

    Seq Age Sex Outcome Treatment
    1 Other