FDA Adverse Event
Injury
Summary report: N
REPLY
MDR report key: 1910499
·
Received November 18, 2010
Report
- Report Number
- 1000165971-2010-00987
- Event Type
- Injury
- Date Received
- November 18, 2010
- Date of Event
- November 4, 2010
- Report Date
- November 10, 2010
- Manufacturer
- SORIN BIOMEDICA CRM S.R.L.
- Product Code
- NVZ
- PMA / PMN Number
- P950029
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(6) 2010. THIS EVENT CONCERNS A DEVICE THAT WAS MANUFACTURED AND USED OUTSIDE THE UNITED STATES. ANALYSIS IS PENDING.
Description of Event or Problem · 1
CONNECTION ISSUES ASSOCIATED WITH THE ATRIAL CHANNEL DURING THE IMPLANTATION PROCEDURE WERE INCURRED. REPORTEDLY, CLICKING OF THE TORQUE-LIMITING SCREWDRIVER WAS NOT OBTAINED DURING THE CONNECTION ATTEMPT. WHEN THE PHYSICIAN REMOVED THE SCREWDRIVER, THE SET-SCREW WAS REMOVED, AS WELL. THE PHYSICIAN WAS THEN ABLE TO RE-INSERT THE SET-SCREW AND APPROPRIATELY CONNECT THE LEAD, BUT DECIDED NOT TO IMPLANT THE SUBJECT DEVICE DUE TO THE DIFFICULTIES OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | REPLY | NVZ | SORIN BIOMEDICA CRM S.R.L. | REPLY DR | 2478 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |