FDA Adverse Event
Malfunction
Summary report: N
ISOLINE
MDR report key: 1959903
·
Received January 13, 2011
Report
- Report Number
- 2182863-2011-00004
- Event Type
- Malfunction
- Date Received
- January 13, 2011
- Date of Event
- November 22, 2010
- Report Date
- December 17, 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 13, 2011. THE ANALYSIS ON THIS DEVICE IS PENDING. APRIL 11, 2011. (B)(4).
Additional Manufacturer Narrative · 1
JANUARY 13, 2011. THE ANALYSIS ON THIS DEVICE IS PENDING.
Description of Event or Problem · 1
DURING THE IMPLANTATION PROCEDURE WHILE TRYING TO MOVE THE LEAD TO A BETTER LOCATION, IT WAS REPORTED THAT THE HELIX WOULD NOT FIXATE. THE FIRST ATTEMPT TO FIXATE WORKED UNTIL IT WAS RELOCATED THEN THE HELIX WOULD NOT COME OUT.
Description of Event or Problem · 1
DURING THE IMPLANTATION PROCEDURE WHILE TRYING TO MOVE THE LEAD TO A BETTER LOCATION, IT WAS REPORTED THAT THE HELIX WOULD NOT FIXATE. THE FIRST ATTEMPT TO FIXATE WORKED UNTIL IT WAS RELOCATED THEN THE HELIX WOULD NOT COME OUT.
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 | 60 YR |