FDA Adverse Event
Malfunction
Summary report: N
ATTAIN ABILITY
MDR report key: 2123377
·
Received June 14, 2011
Report
- Report Number
- 2649622-2011-07959
- Event Type
- Malfunction
- Date Received
- June 14, 2011
- Date of Event
- March 2, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. A DISTAL CONDUCTOR BLOOD/FLUID OBSTRUCTION WAS FOUND. THE GUIDEWIRE COULD NOT BE INSERTED BECAUSE OF THE BLOOD OBSTRUCTION. IT WAS ALSO NOTED THAT ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DOCTOR ATTEMPTED TO BACKLOAD LEAD OVER GUIDE WIRE AND LEAD WOULD NOT SLIDE DOWN WIRE. THE LEAD WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN ABILITY | IMPLANTABLE PACING LEAD | OJX | MEDTRONIC PUERTO RICO, INC. | 4196 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other | 4076 (X2) IMPLANTABLE PACING LEAD| 8042 IMPLANTABLE PULSE GENERATOR |