FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 2790788
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-15369
- Event Type
- Injury
- Date Received
- October 15, 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 LEFT VENTRICULAR LEAD WAS T-WAVE OVERSENSING. THE LEAD WAS REPROGRAMMED AND IS STILL IN USE. THE PATIENT IS ENROLLED IN THE SYSTEMS LONGEVITY STUDY. 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 | 69 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD| D224TRK IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD |