FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 2813525
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16768
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD NOISE, HIGH IMPEDANCE AND WAS FRACTURED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLD DUE TO EXIT BLOCK. THE RV LEAD WAS EXPLANTED AND REPLACED AND THE LV LEAD REMAINS IN USE. 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R | D314TRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 5071 IMPLANTABLE PACING LEAD |