N
Patient 1
THIS PRODUCT IS REGISTERED AS A COMBINATION PRODUCT. THE RESULTS, METHOD, AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
MAUDE MDR 9908368
- MDR report key
- 9908368
- Report number
- 2938836-2020-02371
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-17
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- ELIZABETH BOLTZ
- Address
- 15900 VALLEY VIEW COURT SYLMAR CA 91342 US
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
DURING IMPLANT, IT WAS REPORTED THAT R WAVE AMPLITUDE VARIATION WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. THE HELIX OF THE RV LEAD FAILED TO INSERT AFTER ATTEMPTED IMPLANT. A DIFFERENT RV LEAD WAS USED AND WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE AND THERE WERE NO ADVERSE CONSEQUENCES.