ATTAIN
Report
- Report Number
- 2182208-2013-01380
- Event Type
- Injury
- Date Received
- June 8, 2013
- Report Date
- March 1, 2013
- Manufacturer
- RICE CREEK MFG
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT ID: 6945 PRODUCT ID (B)(4), PRODUCT ID: 5076 PRODUCT EVENT SUMMARY: ANALYSIS FOUND NO ANOMALIES. THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: OCCURRENCE OF PHRENIC NERVE STIMULATION IN CARDIAC RESYNCHRONIZATION THERAPY PATIENTS: THE ROLE OF LEFT VENTRICULAR LEAD TYPE AND PLACEMENT SITE. EUROPACE: EUROPEAN PACING, ARRHYTHMIAS, AND CARDIAC ELECTROPHYSIOLOGY: JOURNAL OF THE WORKING GROUPS ON CARDIAC PACING, ARRHYTHMIAS, AND CARDIAC CELLULAR ELECTROPHYSIOLOGY OF THE EUROPEAN SOCIETY OF CARDIOLOGY. 2013;15(1):77-82. (B)(4).
A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD. THE PATIENT EXPERIENCED DIAPHRAGMATIC MUSCLE STIMULATION 13 DAYS POST IMPLANT. THE POLARITY OF THE LEFT VENTRICULAR (LV) WAS CHANGED TO RESOLVE THE ISSUE AND THE LEAD REMAINED IN USE AT THAT TIME. THE LEAD WAS EXPLANTED AND RETURNED WITH NO INFORMATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255004 | ATTAIN | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | RICE CREEK MFG | 4196 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Hospitalization| R |