FDA Adverse Event
Injury
Summary report: N
ATTAIN STARFIX
MDR report key: 3992487
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09860
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 19, 2014
- Report Date
- June 19, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P060039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 694765 LEAD, IMPLANTED: (B)(6) 2012. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS EARLY BATTERY DEPLETION, POSSIBLY DUE TO HIGH LV (LEFT VENTRICULAR) THRESHOLD REQUIRING HIGH OUTPUTS. THE DEVICE WAS EXPLANTED AND REPLACED, AND THE LV LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 466855 | ATTAIN STARFIX | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00059 YR | Hospitalization| R | D314TRG CRT-D |