N
Patient 1
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
MAUDE MDR 9901377
- MDR report key
- 9901377
- Report number
- 2938836-2020-02320
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-27
- Date received
- 2020-03-30
- 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 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | NVY | 1590/60 | 0002121715 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-30 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR GENERATOR CHANGE. THE RIGHT VENTRICULAR LEAD TESTED NORMALLY IN THE PRE-OP AREA DURING INTERROGATION. IN THE EP LAB, THE LEAD WAS POSITIVE FOR CONDUCTOR EXTERNALIZATIONS UNDER FLUOROSCOPY. THE LEAD WAS CAPPED AND REPLACED ON (B)(6) 2020. THE PATIENT WAS STABLE.