INOGEN EL ICD VR
Report
- Report Number
- 2124215-2024-02582
- Event Type
- Injury
- Date Received
- January 18, 2024
- Date of Event
- December 2, 2023
- Report Date
- July 30, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- PMA / PMN Number
- P960040/S306
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED NO ANOMALIES. REVIEW OF THE DEVICE MEMORY CONFIRMED A LOW VOLTAGE ALERT WAS RECORDED. ALTHOUGH THE DEVICE MEMORY DIAGNOSTICS DEMONSTRATED THE DAILY BATTERY VOLTAGE MEASUREMENTS DISPLAYED AN IRREGULAR PATTERN OF DISCHARGE, THE BATTERY VOLTAGE LEVEL UPON RECEIPT IN THE LABORATORY WAS SUFFICIENT TO ENSURE THERAPY AVAILABILITY/DELIVERY WHILE THE DEVICE WAS IMPLANTED. THE DEVICE CASE WAS THEN OPENED TO FACILITATE ANALYSIS OF THE INTERNAL COMPONENTS. THE BATTERY WAS SEPARATED FROM THE OTHER DEVICE ELECTRONICS AND THE OVERALL CURRENT DRAW OF THE CIRCUITRY WAS MEASURED. A NORMAL CURRENT DRAIN WAS OBSERVED WITHIN THE CIRCUITRY. COLLECTIVELY, THE PATTERN OF IRREGULAR DAILY BATTERY VOLTAGE MEASUREMENTS IN CONJUNCTION WITH NORMAL POWER LEVELS AND DEVICE HYBRID CURRENT DRAW IS CONSISTENT WITH BEHAVIOR OF DEVICES WHERE A LATENT CURRENT LEAKAGE PATH HAS OCCURRED WITHIN THE BATTERY ITSELF, RESULTING IN A PARTIAL DEPLETION OF THE BATTERY. THIS BEHAVIOR IS CAUSED BY A LATENT ELECTRICAL LEAKAGE PATH THAT DEVELOPS OVER TIME BETWEEN THE ANODE AND CATHODE WITHIN THE DEVICE BATTERY. IN CERTAIN CIRCUMSTANCES, LITHIUM METAL IONS CAN RE-PLATE TO FORM CLUSTERS THAT MAY RESULT IN AN INTERNAL CURRENT LEAKAGE. A DESIGN ENHANCEMENT WAS IMPLEMENTED IN 2013 TO ENLARGE THE PHYSICAL BARRIER BETWEEN THE ELECTRODE LAYERS TO PREVENT CURRENT LEAKAGE IN THE AREA OF THE BATTERY THAT IS MOST OFTEN AFFECTED BY THIS BEHAVIOR. ANALYSIS DETERMINED THE FIRST RECORDED INSTANCE OF CODE 1003 OCCURRED ON (B)(6) 2023. AS SUCH, THE EVENT DATE HAS BEEN MODIFIED FROM (B)(6) 2023 ACCORDINGLY.
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED NO ANOMALIES. REVIEW OF THE DEVICE MEMORY CONFIRMED A LOW VOLTAGE ALERT WAS RECORDED. ALTHOUGH THE DEVICE MEMORY DIAGNOSTICS DEMONSTRATED THE DAILY BATTERY VOLTAGE MEASUREMENTS DISPLAYED AN IRREGULAR PATTERN OF DISCHARGE, THE BATTERY VOLTAGE LEVEL UPON RECEIPT IN THE LABORATORY WAS SUFFICIENT TO ENSURE THERAPY AVAILABILITY/DELIVERY WHILE THE DEVICE WAS IMPLANTED. THE DEVICE CASE WAS THEN OPENED TO FACILITATE ANALYSIS OF THE INTERNAL COMPONENTS. THE BATTERY WAS SEPARATED FROM THE OTHER DEVICE ELECTRONICS AND THE OVERALL CURRENT DRAW OF THE CIRCUITRY WAS MEASURED. A NORMAL CURRENT DRAIN WAS OBSERVED WITHIN THE CIRCUITRY. COLLECTIVELY, THE PATTERN OF IRREGULAR DAILY BATTERY VOLTAGE MEASUREMENTS IN CONJUNCTION WITH NORMAL POWER LEVELS AND DEVICE HYBRID CURRENT DRAW IS CONSISTENT WITH BEHAVIOR OF DEVICES WHERE A LATENT CURRENT LEAKAGE PATH HAS OCCURRED WITHIN THE BATTERY ITSELF, RESULTING IN A PARTIAL DEPLETION OF THE BATTERY. THIS BEHAVIOR IS CAUSED BY A LATENT ELECTRICAL LEAKAGE PATH THAT DEVELOPS OVER TIME BETWEEN THE ANODE AND CATHODE WITHIN THE DEVICE BATTERY. IN CERTAIN CIRCUMSTANCES, LITHIUM METAL IONS CAN RE-PLATE TO FORM CLUSTERS THAT MAY RESULT IN AN INTERNAL CURRENT LEAKAGE. A DESIGN ENHANCEMENT WAS IMPLEMENTED IN 2013 TO ENLARGE THE PHYSICAL BARRIER BETWEEN THE ELECTRODE LAYERS TO PREVENT CURRENT LEAKAGE IN THE AREA OF THE BATTERY THAT IS MOST OFTEN AFFECTED BY THIS BEHAVIOR.
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE, AND THIS DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT. BESIDES INTERVENTION, THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED. DEVICE RETURN IS EXPECTED.
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE, AND THIS DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT. BESIDES INTERVENTION, THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. EXTERNAL VISUAL INSPECTION OF THE DEVICE REVEALED NO ANOMALIES. REVIEW OF THE DEVICE MEMORY CONFIRMED A LOW VOLTAGE ALERT WAS RECORDED. ALTHOUGH THE DEVICE MEMORY DIAGNOSTICS DEMONSTRATED THE DAILY BATTERY VOLTAGE MEASUREMENTS DISPLAYED AN IRREGULAR PATTERN OF DISCHARGE, THE BATTERY VOLTAGE LEVEL UPON RECEIPT IN THE LABORATORY WAS SUFFICIENT TO ENSURE THERAPY AVAILABILITY/DELIVERY WHILE THE DEVICE WAS IMPLANTED. THE DEVICE CASE WAS THEN OPENED TO FACILITATE ANALYSIS OF THE INTERNAL COMPONENTS. THE BATTERY WAS SEPARATED FROM THE OTHER DEVICE ELECTRONICS AND THE OVERALL CURRENT DRAW OF THE CIRCUITRY WAS MEASURED. A NORMAL CURRENT DRAIN WAS OBSERVED WITHIN THE CIRCUITRY. COLLECTIVELY, THE PATTERN OF IRREGULAR DAILY BATTERY VOLTAGE MEASUREMENTS IN CONJUNCTION WITH NORMAL POWER LEVELS AND DEVICE HYBRID CURRENT DRAW IS CONSISTENT WITH BEHAVIOR OF DEVICES WHERE A LATENT CURRENT LEAKAGE PATH HAS OCCURRED WITHIN THE BATTERY ITSELF, RESULTING IN A PARTIAL DEPLETION OF THE BATTERY. THIS BEHAVIOR IS CAUSED BY A LATENT ELECTRICAL LEAKAGE PATH THAT DEVELOPS OVER TIME BETWEEN THE ANODE AND CATHODE WITHIN THE DEVICE BATTERY. IN CERTAIN CIRCUMSTANCES, LITHIUM METAL IONS CAN RE-PLATE TO FORM CLUSTERS THAT MAY RESULT IN AN INTERNAL CURRENT LEAKAGE. A DESIGN ENHANCEMENT WAS IMPLEMENTED IN 2013 TO ENLARGE THE PHYSICAL BARRIER BETWEEN THE ELECTRODE LAYERS TO PREVENT CURRENT LEAKAGE IN THE AREA OF THE BATTERY THAT IS MOST OFTEN AFFECTED BY THIS BEHAVIOR.
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECORDED A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE, AND THIS DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT. BESIDES INTERVENTION, THERE WERE NO OTHER ADVERSE PATIENT EFFECTS REPORTED. ADDITIONAL INFORMATION: THIS PRODUCT WAS RETURNED, AND ANALYSIS WAS COMPLETED. THIS REPORT IS UPDATED WITH THE PRODUCT INVESTIGATION RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 421488 | INOGEN EL ICD VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | D140 | 206794 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention| H |