FDA Adverse Event
Malfunction
Summary report: N
REPLY SR
MDR report key: 2122146
·
Received June 13, 2011
Report
- Report Number
- 2182863-2011-00053
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- May 16, 2011
- Report Date
- May 16, 2011
- Manufacturer
- SORIN BIOMEDICA CRM S.R.L.
- Product Code
- DXY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4), 2011.THE ANALYSIS ON THIS DEVICE IS PENDING.
Additional Manufacturer Narrative · 1
(B)(4) 2011. THE ANALYSIS ON THIS DEVICE IS PENDING.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANTATION PROCEDURE UPON TIGHTENING THE SETSCREW DOWN, THEY DID NOT HEAR A "CLICK" . THE DEVICE WAS NOT IMPLANTED; A NEW REPLY WAS IMPLANTED SUCCESSFULLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANTATION PROCEDURE UPON TIGHTENING THE SETSCREW DOWN, THEY DID NOT HEAR A "CLICK" . THE DEVICE WAS NOT IMPLANTED; A NEW REPLY WAS IMPLANTED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLY SR | CARDIAC PACEMAKER | DXY | SORIN BIOMEDICA CRM S.R.L. | REPLY SR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR |