FDA Adverse Event
Malfunction
Summary report: N
REPLY DR
MDR report key: 1942338
·
Received December 30, 2010
Report
- Report Number
- 2182863-2010-00132
- Event Type
- Malfunction
- Date Received
- December 30, 2010
- Date of Event
- November 4, 2010
- Report Date
- December 2, 2010
- Manufacturer
- SORIN BIOMEDICA CRM S.R.L.
- Product Code
- DXY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DECEMBER 30, 2010. THE ANALYSIS ON THIS DEVICE IS PENDING.
Additional Manufacturer Narrative · 1
(B)(4) 2010. THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4) 2011.
Description of Event or Problem · 1
DURING THE IMPLANTATION PROCEDURE, THE SETSCREW CAME OUT OF THE HEADER. THEREFORE, IT WAS NOT IMPLANTED. A NEW REPLY DEVICE WAS IMPLANTED SUCCESSFULLY.
Description of Event or Problem · 1
DURING THE IMPLANTATION PROCEDURE, THE SETSCREW CAME OUT OF THE HEADER. THEREFORE, IT WAS NOT IMPLANTED. A NEW REPLY DEVICE WAS IMPLANTED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLY DR | CARDIAC PACEMAKER | DXY | SORIN BIOMEDICA CRM S.R.L. | REPLY DR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |