N
Patient 1
THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.
MAUDE MDR 9863717
- MDR report key
- 9863717
- Report number
- 2938836-2020-02092
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-06
- Date received
- 2020-03-22
- 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#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | VICTORY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | DXY | 5816 | 5816 | 3224548 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-22 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED FOR DEVICE REPLACEMENT DUE TO NORMAL ERI, REQUIRED PROGRAMMING CHANGES WERE MADE TO THE DEVICE AS PATIENT DID NOT HAVE ANY INTRINSIC RHYTHM. DURING THE PROCEDURE, THE PHYSICIAN USED ELECTROSURGERY WHEN THE ELECTROCARDIOGRAM PAUSED. DEVICE INTERROGATION REVEALED SANE PROGRAMMED SETTING. THE PHYSICIAN PROCEEDED WITH ELECTROSURGERY AGAIN WHEN THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. THE DEVICE WAS REPLACED, AND PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES AND WAS DISCHARGED.