FDA Adverse Event
Malfunction
Summary report: N
SENTUS PROMRI OTW QP S-85/49
MDR report key: 12728034
·
Received November 1, 2021
Report
- Report Number
- 1028232-2021-05936
- Event Type
- Malfunction
- Date Received
- November 1, 2021
- Date of Event
- October 25, 2021
- Report Date
- October 26, 2021
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- OJX
- UDI-DI
- 04035479145606
- PMA / PMN Number
- P070008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 0
THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT. THE FILE IS CLOSED. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.
Description of Event or Problem · 1
LEAD CAPPED DUE TO NOT CAPTURING AT MAX OUTPUT ALL VECTORS. PHYSICIAN SELECTED NEW TARGET VESSEL AND REQUESTED QP-L FIXATION. NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE ADDED TO THIS FILE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1627708 | SENTUS PROMRI OTW QP S-85/49 | LV LEAD | OJX | BIOTRONIK SE & CO. KG | 406082 | 04035479145606 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Hospitalization |