FDA Adverse Event
Malfunction
Summary report: N
CYLOS DR
MDR report key: 2231029
·
Received July 19, 2011
Report
- Report Number
- 1028232-2011-01644
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- May 2, 2011
- Report Date
- July 6, 2011
- 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
THIS DEVICE WAS RETURNED WITHOUT (B)(4). THE FOLLOWING PHYSICIAN'S OFFICE HAS NOT SEEN THIS PATIENT SINCE 2009. ON (B)(6) 2011 - INFORMATION WAS RECEIVED THAT THIS DEVICE WAS REPLACED WITH A COMPETITOR'S DEVICE ON (B)(6) 2011 BECAUSE IT HAD BEEN "DAMAGED AFTER AN MRI". SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS COMPLAINT WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYLOS DR | PACEMAKER | NVZ | BIOTRONIK SE & CO. KG | 349799 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Hospitalization |