FDA Adverse Event
Injury
Summary report: N
ATTAIN STARFIX
MDR report key: 4161746
·
Received October 10, 2014
Report
- Report Number
- 2649622-2014-11413
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- August 8, 2014
- Report Date
- August 8, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P060039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, 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. CONCOMITANT MEDICAL PRODUCTS: 5076-52, LEAD, IMPLANTED: (B)(6) 2009; 694765, LEAD, IMPLANTED: (B)(6) 2009. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS HAVING EXTRACARDIAC STIMULATION DUE TO THE LEFT VENTRICULAR (LV) LEAD. THE 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 |
|---|---|---|---|---|---|---|---|
| 639265 | ATTAIN STARFIX | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00064 YR | Hospitalization| R | D314TRG ICD |