INGENIO
Report
- Report Number
- 2124215-2023-71606
- Event Type
- Injury
- Date Received
- December 18, 2023
- Date of Event
- November 27, 2023
- Report Date
- August 27, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED TO UPDATE THE PATIENT IDENTIFIER.
THIS DEVICE WAS EXPECTED TO BE RETURNED. SHOULD THE DEVICE BE RETURNED ANALYSIS WILL BE CONDUCTED AND THIS INVESTIGATION WILL BE UPDATED.
THIS CRT-P WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. THE DEVICE COULD NOT BE INTERROGATED AND WAS EXHIBITING NO PACING PULSES. THE DEVICE CASE WAS REMOVED TO FACILITATE INSPECTION AND TESTING OF THE INTERNAL COMPONENTS. THE BATTERY WAS REMOVED AND REPLACED WITH AN EXTERNAL POWER SOURCE. TESTING CONFIRMED A NORMAL CURRENT DRAIN. THE BATTERY WAS FORWARDED FOR DETAILED ANALYSIS AND WHILE THE BATTERY WAS CONFIRMED TO BE DEPLETED, THE ROOT CAUSE WAS UNABLE TO BE DETERMINED.
IT WAS REPORTED THAT THE PATIENT HAD REPORTED TO THE HEALTH CARE PROFESSIONAL THAT THEIR PULSE RATE WAS FIFTY BEATS PER MINUTE. THE PATIENT WAS IN ARGENTINA ON HOLIDAY AND A RECENT CHECK SHOWED NEARING EXPLANT. THE HEALTHCARE PROFESSIONAL WAS GOING TO CONTACT THE PATIENT. TECHNICAL SERVICES (TS) DISCUSSED THAT PACING BELOW THE LOWER RATE LIMIT (LRL) CAN BE PRESENT BECAUSE OF MODIFIED - BASED TIMING AS WELL AS PREMATURE VENTRICULAR CONTRACTION (PVC) IDENTIFICATION. IN THIS CASE, THERE IS EVIDENCE OF NOISE OVERSENSING, LEADING TO THE DEVICE PACING BELOW THE LRL. ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE WAS FOUND TO BE IN SAFETY MODE AND THE PATIENT UNDERWENT URGENT DEVICE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THE PATIENT HAD REPORTED TO THE HEALTH CARE PROFESSIONAL THAT THEIR PULSE RATE WAS FIFTY BEATS PER MINUTE. THE PATIENT WAS IN ARGENTINA ON HOLIDAY AND A RECENT CHECK SHOWED NEARING EXPLANT. THE HEALTHCARE PROFESSIONAL WAS GOING TO CONTACT THE PATIENT. TECHNICAL SERVICES (TS) DISCUSSED THAT PACING BELOW THE LOWER RATE LIMIT (LRL) CAN BE PRESENT BECAUSE OF MODIFIED - BASED TIMING AS WELL AS PREMATURE VENTRICULAR CONTRACTION (PVC) IDENTIFICATION. IN THIS CASE, THERE IS EVIDENCE OF NOISE OVERSENSING, LEADING TO THE DEVICE PACING BELOW THE LRL. ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE WAS FOUND TO BE IN SAFETY MODE AND THE PATIENT UNDERWENT URGENT DEVICE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.
IT WAS REPORTED THAT THE PATIENT HAD REPORTED TO THE HEALTH CARE PROFESSIONAL THAT THEIR PULSE RATE WAS FIFTY BEATS PER MINUTE. THE PATIENT WAS IN ARGENTINA ON HOLIDAY AND A RECENT CHECK SHOWED NEARING EXPLANT. THE HEALTHCARE PROFESSIONAL WAS GOING TO CONTACT THE PATIENT. TECHNICAL SERVICES (TS) DISCUSSED THAT PACING BELOW THE LOWER RATE LIMIT (LRL) CAN BE PRESENT BECAUSE OF MODIFIED - BASED TIMING AS WELL AS PREMATURE VENTRICULAR CONTRACTION (PVC) IDENTIFICATION. IN THIS CASE, THERE IS EVIDENCE OF NOISE OVERSENSING, LEADING TO THE DEVICE PACING BELOW THE LRL. ADDITIONAL INFORMATION WAS RECEIVED. THE DEVICE WAS FOUND TO BE IN SAFETY MODE AND THE PATIENT UNDERWENT URGENT DEVICE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67172 | INGENIO | IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) | LWP | BOSTON SCIENTIFIC CORPORATION | J177 | 483092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R |