FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 2810664
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16287
- 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
- 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF THUMPING IN THE CHEST DUE TO EXTRACARDIAC STIMULATION FROM THE LEFT VENTRICULAR (LV) LEAD. NO ACTION IS PLANNED. IT WAS ALSO REPORTED THAT THE CAPTURE THRESHOLD OF THE LEAD HAS INCREASED. THE LEAD POLARITY WAS REPROGRAMMED TO BIPOLAR AND THE THRESHOLD IS BETTER. THE LEAD REMAINS IN USE. THE PATIENT IS ENROLLED IN THE (B)(4) STUDY. NO FURTHER 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 | 78 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |