FDA Adverse Event
Injury
Summary report: N
ISOLINE
MDR report key: 2091741
·
Received May 17, 2011
Report
- Report Number
- 2182863-2011-00036
- Event Type
- Injury
- Date Received
- May 17, 2011
- Date of Event
- April 15, 2011
- Report Date
- April 18, 2011
- Manufacturer
- SORIN BIOMEDICA CRM S.R.L.
- Product Code
- MRM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) 2011. A RESPONSE FROM THE MANUFACTURER IS PENDING. DEVICE WAS NOT RETURNED.
Additional Manufacturer Narrative · 1
(B)(4), 2011, A RESPONSE FROM THE MANUFACTURER IS PENDING. (B)(4), 2011, SINCE THE DEVICE WAS NOT RETURNED, THE PRODUCTION HISTORY AND STERILIZATION RECORDS WERE REVIEWED. THE RECORDS SHOWED THE DEVICE WAS MANUFACTURED, STERILIZED AND RELEASED ACCORDING TO APPLICABLE STANDARD OPERATING PROCEDURES. (B)(4): DEVICE WAS NOT RETURNED.
Description of Event or Problem · 1
THIS LEAD WAS EXPLANTED BECAUSE OF AN INFECTION.
Description of Event or Problem · 1
THIS LEAD WAS EXPLANTED BECAUSE OF AN INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ISOLINE | LEAD | MRM | SORIN BIOMEDICA CRM S.R.L. | 2CR-6 | 2497 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R |