FDA Adverse Event
Malfunction
Summary report: N
DEXATIP
MDR report key: 1991399
·
Received February 15, 2011
Report
- Report Number
- 2182208-2011-00146
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- PMA / PMN Number
- P850089/S17
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WOULD NOT PASS THE DISTAL SCREW SET OF THE COMPETITORS DEVICE. A NEW DEVICE WAS SELECTED AND SUCCESSFULLY IMPLANTED WITH THE RIGHT VENTRICULAR (RV) LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEXATIP | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC, INC. | 4262 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |