FDA Adverse Event
Malfunction
Summary report: N
ISOLINE
MDR report key: 1962102
·
Received January 17, 2011
Report
- Report Number
- 2182863-2011-00005
- Event Type
- Malfunction
- Date Received
- January 17, 2011
- Date of Event
- October 21, 2010
- Report Date
- December 20, 2010
- Manufacturer
- SORIN BIOMEDICA CRM S.R.L.
- Product Code
- MRM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
JANUARY 17, 2011. THE ANALYSIS ON THIS DEVICE IS PENDING. APRIL 11, 2011. (B)(4).
Additional Manufacturer Narrative · 1
JANUARY 17, 2011. THE ANALYSIS ON THIS DEVICE IS PENDING.
Description of Event or Problem · 1
DURING THE IMPLANT PROCEDURE, IT WAS REPORTED THAT THE LEAD WAS RE-POSITIONED FOR BETTER NUMBERS, THEN THE HELIX WOULD NOT FIXATE. THE LEAD WAS NOT IMPLANTED.
Description of Event or Problem · 1
DURING THE IMPLANT PROCEDURE, IT WAS REPORTED THAT THE LEAD WAS RE-POSITIONED FOR BETTER NUMBERS, THEN THE HELIX WOULD NOT FIXATE. THE LEAD WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOLINE | LEAD | MRM | SORIN BIOMEDICA CRM S.R.L. | 2CR-6 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |