FDA Adverse Event
Injury
Summary report: N
ASKU
MDR report key: 1991642
·
Received February 15, 2011
Report
- Report Number
- 2182208-2011-00152
- Event Type
- Injury
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DQX
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
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. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE GUIDE WIRE TIP BROKE OFF IN THE BRANCH OF THE CORONARY SINUS OF THE PATIENT. THE GUIDE WIRE TIP WAS LEFT IN THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ASKU | GUIDE WIRE | DQX | MEDTRONIC, INC. | GUIDEWIRE | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD| 4196 IMPLANTABLE PACING LEAD |