FDA Adverse Event
Injury
Summary report: N
DYC 60 UP
MDR report key: 50129
·
Received November 15, 1996
Report
- Report Number
- 1028232-1996-00037
- Event Type
- Injury
- Date Received
- November 15, 1996
- Date of Event
- January 22, 1996
- Report Date
- November 12, 1996
- Manufacturer
- BIOTRONIC, GMBH
- Product Code
- DTB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
NO STIMULATION. X-RAY INDICATES THAT THE LEAD IS CLAMPED BETWEEN THE FIRST RIB AND CLAVICLE "SUBCLAVIAN CRUSH".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DYC 60 UP Implant | LEAD, PACEMAKER | DTB | BIOTRONIC, GMBH | DYC 60 UP | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Hospitalization |