FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 2952192
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00454
- Event Type
- Injury
- Date Received
- February 9, 2013
- Report Date
- November 13, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P010015/S012
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS EVENT OCCURRED OUTSIDE OF THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEADS WERE CAUSING DIAPHRAGMATIC STIMULATION. THE LV OUTPUT WAS REPROGRAMMED AND THE LEADS REMAIN 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 |
|---|---|---|---|---|---|---|---|
| 56468 | ATTAIN OTW | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 419478 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | Required Intervention | 4193 IMPLANTABLE PACING LEAD |