FDA Adverse Event
Injury
Summary report: N
ATTAIN STARFIX
MDR report key: 2951794
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-00234
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- October 24, 2012
- Report Date
- November 7, 2012
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P060039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD THRESHOLD INCREASED FROM 0.75 V @ 0.4 MS TO 1.75 V @ 0.4 MS. THE OUTPUT ON THE LEAD WAS REPROGRAMMED AND THE LEAD REMAINS IN USE. IT WAS NOTED THAT THE PATIENT IS TAKING PART IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56379 | ATTAIN STARFIX | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 419588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | Required Intervention | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |