FDA Adverse Event
Other
Summary report: N
ISOLINE
MDR report key: 1085178
·
Received July 25, 2008
Report
- Report Number
- 2182863-2008-00043
- Event Type
- Other
- Date Received
- July 25, 2008
- Date of Event
- June 16, 2008
- Report Date
- July 25, 2008
- Manufacturer
- SORIN BIOMEDICA CRM S.R. L.
- Product Code
- DTB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
COILS STRETCHED DURING IMPLANT PROCEDURE, THE LEAD WAS NOT IMPLANTED. THE ANALYSIS ON THIS DEVICE IS PENDING.
Description of Event or Problem · 1
DURING THE IMPLANTATION PROCEDURE, THE COIL ON THIS LEAD GOT STRETCHED OUT. REPORTEDLY, THERE WAS DIFFICULT VENOUS ACCESS. THEREFORE, THE LEAD WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOLINE | 2CR-5 | DTB | SORIN BIOMEDICA CRM S.R. L. | 2CR-5 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |