FDA Adverse Event
Malfunction
Summary report: N
CYLOS DR-T
MDR report key: 2578492
·
Received May 11, 2012
Report
- Report Number
- 1028232-2012-01192
- Event Type
- Malfunction
- Date Received
- May 11, 2012
- Date of Event
- February 22, 2012
- Report Date
- February 22, 2012
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- NVZ
- PMA / PMN Number
- P950037
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
UPON INTERROGATION, THIS DEVICE REQUIRED RE-INITIALIZATION. RE-INITIALIZATION WAS UNSUCCESSFUL AFTER SEVERAL ATTEMPTS. THE PT WAS IN POST-OPERATIVE RECOVERY AFTER A THORACIC SURGICAL PROCEDURE. THERE ARE NO ADVERSE PT EVENTS REPORTED DURING OR AFTER THE SURGICAL PROCEDURE. ON (B)(6) 2012, THIS DEVICE CURRENTLY REMAINS IMPLANTED. THERE ARE PLANS TO EVENTUALLY EXPLANT THIS DEVICE, BUT THERE IS NO DATE SET. THIS FILE WILL BE UPDATED IF ADD'L INFO IS PROVIDED. ON (B)(6) 2012, THIS DEVICE WAS RETURNED AND IS AT ERI INDICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYLOS DR-T | PACEMAKER | NVZ | BIOTRONIK SE & CO. KG | 349806 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization |