FDA Adverse Event
Death
Summary report: N
BERLIN HEART EXCOR PEDIATRIC VAD
MDR report key: 8345256
·
Received February 15, 2019
Report
- Report Number
- 3004582654-2019-00015
- Event Type
- Death
- Date Received
- February 15, 2019
- Date of Event
- January 23, 2019
- Report Date
- February 15, 2019
- Manufacturer
- BERLIN HEART GMBH
- Product Code
- DSQ
- PMA / PMN Number
- P160035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). PATIENT WAS ON EXCOR SYSTEM FROM (B)(6) 2018 TO (B)(6) 2019 (105 DAYS). DUE TO DATA PRIVACY PROTECTION LAWS IN EUROPE, THE PROVIDER DID NOT PROVIDE PATIENT RELATED DATA. ADVERSE EVENT TERM: HEMORRHAGIC CVA.
Description of Event or Problem · 0
THE DISTRIBUTOR CONTACTED BERLIN HEART (B)(4) ON (B)(6) 2019 TO REPORT A PATIENT SUPPORTED ON THE EXCOR BLOOD PUMP HAD A HEMORRHAGIC CVA AND DIED ON (B)(6) 2019. THE DISTRIBUTOR TRIED CONTACTING THE SITE, BUT NO ADDITIONAL INFORMATION WAS FORTHCOMING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139224 | BERLIN HEART EXCOR PEDIATRIC VAD | VENTRICULAR ASSIST DEVICE | DSQ | BERLIN HEART GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |