FDA Adverse Event
Malfunction
Summary report: N
SITUS
MDR report key: 2111407
·
Received June 2, 2011
Report
- Report Number
- 2182863-2011-00046
- Event Type
- Malfunction
- Date Received
- June 2, 2011
- Date of Event
- March 29, 2011
- Report Date
- May 4, 2011
- Manufacturer
- SORIN BIOMEDICA CRM S.R.L.
- Product Code
- NIK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4), 2011.THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4), 2011.(B)(4)
Additional Manufacturer Narrative · 1
(B)(6) 2011, THE ANALYSIS ON THIS DEVICE IS PENDING.
Description of Event or Problem · 1
DURING THE IMPLANTATION PROCEDURE, THERE WAS BAD CAPTURE, HIGH IMPEDANCE READINGS AROUND 1700 AND NO SENSING. THE LEAD WAS NOT IMPLANTED, ANOTHER SITUS LEAD WAS IMPLANTED SUCCESSFULLY.
Description of Event or Problem · 1
DURING THE IMPLANTATION PROCEDURE, THERE WAS BAD CAPTURE, HIGH IMPEDANCE READINGS AROUND 1700 AND NO SENSING. THE LEAD WAS NOT IMPLANTED, ANOTHER SITUS LEAD WAS IMPLANTED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SITUS | LEAD | NIK | SORIN BIOMEDICA CRM S.R.L. | UW28D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |