INGENIO
Report
- Report Number
- 2124215-2022-35420
- Event Type
- Injury
- Date Received
- September 12, 2022
- Date of Event
- August 15, 2022
- Report Date
- June 16, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. REVIEW OF DEVICE MEMORY NOTED NO SUSPICIOUS FAULTS OR RESETS. POWER CONSUMPTION WAS NOTED TO BE STABLE, AND FULL DEVICE FUNCTION WAS VERIFIED. A SERIES OF AUTOMATED ELECTRICAL/FUNCTIONAL TESTS WERE CONDUCTED AND NO ISSUES WITH DEVICE PERFORMANCE WERE OBSERVED; BASIC SENSING AND PACING FUNCTIONS OF THE DEVICE WERE VERIFIED. THE TITANIUM CASE WAS THEN OPENED AND THE BATTERY WAS REMOVED SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A HIGHER-THAN-NORMAL CURRENT DRAIN WAS OBSERVED, AND GREAT BATCH BATTERY USE WAS CONFIRMED. THE CURRENT DRAIN MALFUNCTION IS ASSOCIATED WITH THE SUPPLIED BATTERY COMPONENT. THIS CORRECTIVE REPORT IS BEING SUBMITTED TO INFORM THE ABOVE DEVICE EVALUATION RESULTS HAVE AN INCORRECT SENTENCE, PLEASE REVIEW THE TEXT BELLOW FOR THE ACCURATE RESULTS OF THE COMPLAINT PACEMAKER ANALYSIS. THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. REVIEW OF DEVICE MEMORY NOTED NO SUSPICIOUS FAULTS OR RESETS. POWER CONSUMPTION WAS NOTED TO BE STABLE, AND FULL DEVICE FUNCTION WAS VERIFIED. REVIEW OF BATTERY VOLTAGE WHILE THE DEVICE WAS IMPLANTED CONFIRMED THE VOLTAGE WAS DROPPING MORE QUICKLY THAN EXPECTED. A SERIES OF AUTOMATED ELECTRICAL/FUNCTIONAL TESTS WERE CONDUCTED AND NO ISSUES WITH DEVICE PERFORMANCE WERE OBSERVED; BASIC SENSING AND PACING FUNCTIONS OF THE DEVICE WERE VERIFIED. THE TITANIUM CASE WAS THEN OPENED, AND THE BATTERY WAS REMOVED SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A NORMAL CURRENT DRAIN WAS THEN OBSERVED. ANALYSIS CONCLUDED THIS BATTERY EXHIBITED A PERFORMANCE ISSUE THAT RESULTED IN THE OBSERVED PREMATURE BATTERY DEPLETION.
THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY. REVIEW OF DEVICE MEMORY NOTED NO SUSPICIOUS FAULTS OR RESETS. POWER CONSUMPTION WAS NOTED TO BE STABLE, AND FULL DEVICE FUNCTION WAS VERIFIED. A SERIES OF AUTOMATED ELECTRICAL/FUNCTIONAL TESTS WERE CONDUCTED AND NO ISSUES WITH DEVICE PERFORMANCE WERE OBSERVED; BASIC SENSING AND PACING FUNCTIONS OF THE DEVICE WERE VERIFIED. THE TITANIUM CASE WAS THEN OPENED AND THE BATTERY WAS REMOVED SO THAT AN EXTERNAL POWER SUPPLY COULD BE CONNECTED TO THE DEVICE FOR FURTHER ANALYSIS. A HIGHER-THAN-NORMAL CURRENT DRAIN WAS OBSERVED, AND GREAT BATCH BATTERY USE WAS CONFIRMED. THE CURRENT DRAIN MALFUNCTION IS ASSOCIATED WITH THE SUPPLIED BATTERY COMPONENT.
IT WAS REPORTED THAT THE BATTERY OF THIS IMPLANTABLE DEVICE WAS SUSPECTED TO BE DEPLETING PREMATURELY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. AS A RESULT, DEVICE REPLACEMENT WITHIN 90 DAYS OR MORE FREQUENT MONITORING WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS SUSPECTED TO BE DEPLETING PREMATURELY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. AS A RESULT, DEVICE REPLACEMENT WITHIN 90 DAYS OR MORE FREQUENT MONITORING WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THIS PACEMAKER WAS SUCCESSFULLY REPLACED AND IS EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS SUSPECTED TO BE DEPLETING PREMATURELY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. AS A RESULT, DEVICE REPLACEMENT WITHIN 90 DAYS OR MORE FREQUENT MONITORING WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THIS PACEMAKER WAS SUCCESSFULLY REPLACED AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THE BATTERY OF THIS PACEMAKER WAS SUSPECTED TO BE DEPLETING PREMATURELY. A REQUEST WAS MADE TO HAVE DATA FROM THIS DEVICE ANALYZED. DATA ANALYSIS CONFIRMED THE BATTERY APPEARED TO BE DEPLETING MORE QUICKLY THAN EXPECTED. AS A RESULT, DEVICE REPLACEMENT WITHIN 90 DAYS OR MORE FREQUENT MONITORING WAS RECOMMENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THIS PACEMAKER WAS SUCCESSFULLY REPLACED AND RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2755931 | INGENIO | PACEMAKER | LWW | BOSTON SCIENTIFIC CORPORATION | J172 | 103435 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| H |