LUX-DX INSERTABLE CARDIAC MONITOR
Report
- Report Number
- 2124215-2023-74714
- Event Type
- Injury
- Date Received
- January 2, 2024
- Date of Event
- August 3, 2023
- Report Date
- April 8, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MXD
- UDI-DI
- 00802526607103
- PMA / PMN Number
- K193473
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
IT WAS REPORTED THAT THE PATIENT THOUGHT SHE MAY BE ALLERGIC TO HER INSERTABLE CARDIAC MONITOR (ICM) AND ASKED THE MATERIAL THE DEVICE WAS MADE FROM. TECHNICAL SERVICES (TS) ADVISED IT IS MADE FROM TITANIUM AND WHAT AN ALLERGIC REACTION MAY INVOLVE. THE PATIENT WAS CONCERNED DUE TO SWELLING AT THE SITE AS WELL AS ITCHING AND WAS REFERRED BY TS TO HER FOLLOWING PHYSICIAN. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INSERTABLE CARDIAC MONITOR (ICM) WAS EXPLANTED WITH NO REPLACEMENT DEVICE IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THE PATIENT THOUGHT SHE MAY BE ALLERGIC TO HER INSERTABLE CARDIAC MONITOR (ICM) AND ASKED THE MATERIAL THE DEVICE WAS MADE FROM. TECHNICAL SERVICES (TS) ADVISED IT IS MADE FROM TITANIUM AND WHAT AN ALLERGIC REACTION MAY INVOLVE. THE PATIENT WAS CONCERNED DUE TO SWELLING AT THE SITE AS WELL AS ITCHING AND WAS REFERRED BY TS TO HER FOLLOWING PHYSICIAN. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INSERTABLE CARDIAC MONITOR (ICM) WAS EXPLANTED WITH NO REPLACEMENT DEVICE IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1227730 | LUX-DX INSERTABLE CARDIAC MONITOR | RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION) | MXD | BOSTON SCIENTIFIC CORPORATION | M301 | 167167 | 00802526607103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Unknown | Required Intervention| H |