FDA Adverse Event
Malfunction
Summary report: N
ATTAIN OTW
MDR report key: 1922330
·
Received December 13, 2010
Report
- Report Number
- 2182208-2010-00947
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- September 10, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DTB
- PMA / PMN Number
- P010015/S012
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 DURING AN IMPLANT OPERATION, THE PHYSICIAN HAD DIFFICULTY GETTING THE GUIDE WIRE TO GO THROUGH THE END OF THE LEFT VENTRICULAR (LV) LEAD THEY WERE TRYING TO IMPLANT. THE GUIDE WIRE EVENTUALLY WENT THROUGH AND THE LEAD WAS IMPLANTED. THERE IS NO DOCUMENTATION AVAILABLE OF THE LEAD'S SERIAL NUMBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN OTW | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC, INC. | 4194 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |