LUX-DX INSERTABLE CARDIAC MONITOR
Report
- Report Number
- 2124215-2023-01690
- Event Type
- Injury
- Date Received
- January 17, 2023
- Date of Event
- December 29, 2022
- Report Date
- May 5, 2023
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MXD
- UDI-DI
- 00802526607103
- PMA / PMN Number
- K193473
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DEVICE HAS BEEN RETURNED FOR ANALYSIS AND THE PRODUCT INVESTIGATION COMPLETED. ANALYSIS OF THE RETURNED PRODUCT IS NOT ABLE TO PROVIDE RELEVANT INFORMATION FOR THE DEHISCENCE ALLEGATION; HOWEVER, DEHISCENCE IS A KNOWN MEDICAL RISK ASSOCIATED WITH THE IMPLANTATION OF A DEVICE UNDER THE SKIN. AS A RESULT, EVALUATION CONCLUSION CODE "KNOWN INHERENT RISK OF DEVICE" WAS ADDED.
THIS CORRECTION SUPPLEMENTAL REPORT WAS SUBMITTED BASED ON A CHANGE TO IMPACT CODE FIELDS IN H6 AND F10.
IT WAS REPORTED THAT AT THE SCHEDULED INSERTABLE CARDIAC MONITOR (ICM) DEVICE IMPLANT PROCEDURE THE PHYSICIAN HAD ISSUES WITH THE IMPLANT TOOL. ADDITIONAL INFORMATION ABOUT THE ISSUES THE PHYSICIAN EXPERIENCED WITH THE IMPLANT TOOL WERE REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED. A MONTH LATER THE PATIENT WAS SEEN AT THE HEALTHCARE FACILITY (HCF). THE BOSTON SCIENTIFIC REPRESENTATIVE PROVIDED THE ICM DEVICE WAS NO LONGER IMPLANTED, THE PATIENT REMOVED THE ICM DEVICE A COUPLE WEEKS PRIOR TO THE HCF VISIT. ANOTHER ICM DEVICE HAS SUBSEQUENTLY BEEN IMPLANTED. THE DEVICE HAS BEEN RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT THIS INSERTABLE CARDIAC MONITOR (ICM) DEVICE CAME OUT OF THE PATIENT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECEIVED A CALL FROM THE BOSTON SCIENTIFIC REPRESENTATIVE. THE PATIENT WAS SEEN AT THE HEALTHCARE FACILITY (HCF). THE BOSTON SCIENTIFIC REPRESENTATIVE PROVIDED THE ICM DEVICE WAS NO LONGER IMPLANTED, THE PATIENT REMOVED THE ICM DEVICE A COUPLE WEEKS PRIOR TO THE HCF VISIT. NO OTHER DEVICES HAVE BEEN SUBSEQUENTLY IMPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT AT THE SCHEDULED INSERTABLE CARDIAC MONITOR (ICM) DEVICE IMPLANT PROCEDURE THE PHYSICIAN HAD ISSUES WITH THE IMPLANT TOOL. ADDITIONAL INFORMATION ABOUT THE ISSUES THE PHYSICIAN EXPERIENCED WITH THE IMPLANT TOOL WERE REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED. A MONTH LATER THE PATIENT WAS SEEN AT THE HEALTHCARE FACILITY (HCF). THE BOSTON SCIENTIFIC REPRESENTATIVE PROVIDED THE ICM DEVICE WAS NO LONGER IMPLANTED, THE PATIENT REMOVED THE ICM DEVICE A COUPLE WEEKS PRIOR TO THE HCF VISIT. NO OTHER DEVICES HAVE BEEN SUBSEQUENTLY IMPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
IT WAS REPORTED THAT AT THE SCHEDULED INSERTABLE CARDIAC MONITOR (ICM) DEVICE IMPLANT PROCEDURE THE PHYSICIAN HAD ISSUES WITH THE IMPLANT TOOL. ADDITIONAL INFORMATION ABOUT THE ISSUES THE PHYSICIAN EXPERIENCED WITH THE IMPLANT TOOL WERE REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED. A MONTH LATER THE PATIENT WAS SEEN AT THE HEALTHCARE FACILITY (HCF). THE BOSTON SCIENTIFIC REPRESENTATIVE PROVIDED THE ICM DEVICE WAS NO LONGER IMPLANTED, THE PATIENT REMOVED THE ICM DEVICE A COUPLE WEEKS PRIOR TO THE HCF VISIT. NO OTHER DEVICES HAVE BEEN SUBSEQUENTLY IMPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1656770 | LUX-DX INSERTABLE CARDIAC MONITOR | RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION) | MXD | BOSTON SCIENTIFIC CORPORATION | M301 | 165063 | 00802526607103 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Unknown | Other |