FDA Adverse Event
Injury
Summary report: N
ATTAIN STARFIX LEAD
MDR report key: 3993846
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-09102
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- April 20, 2014
- Report Date
- December 20, 2019
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P060039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
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: 407645 LEAD, IMPLANTED: (B)(6) 2013; 6947M55 LEAD, IMPLANTED: (B)(6) 2013. (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 DURING THRESHOLD TESTING OF THE LEFT VENTRICULAR (LV) LEAD THE PATIENT EXPERIENCED DIAPHRAGMATIC STIMULATION; VISIBLE ABDOMINAL "JUMPING" WAS NOTED. THE LV LEAD OUTPUT WAS REDUCED AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS PART OF THE (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470954 | ATTAIN STARFIX LEAD | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | Required Intervention | D314TRM CRT-D |