FDA Adverse Event
Injury
Summary report: N
ATTAIN STARFIX
MDR report key: 3992438
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09885
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 24, 2014
- Report Date
- June 24, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P060039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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. PRODUCTS: 330158 LEAD IMPLANTED: 1995 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, THE LEAD WAS REPOSITIONED INTO THE ATRIAL PORT OF THE NEW DEVICE AND REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 467719 | ATTAIN STARFIX | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | Hospitalization| R | 8042B IPG |