FDA Adverse Event
Malfunction
Summary report: N
ATTAIN STARFIX
MDR report key: 3990192
·
Received August 7, 2014
Report
- Report Number
- 2649622-2014-08764
- Event Type
- Malfunction
- Date Received
- August 7, 2014
- Date of Event
- May 19, 2014
- Report Date
- May 19, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P060039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, 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. PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT TWO DIFFERENT LEFT VENTRICULAR (LV) LEAD MODELS WERE ATTEMPTED TO BE IMPLANTED, HOWEVER THERE WERE POOR THRESHOLDS THROUGHOUT THE AVAILABLE BRANCHES. AN EPICARDIAL LEAD WAS LATER IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 463432 | ATTAIN STARFIX | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR |