FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 3241504
·
Received July 22, 2013
Report
- Report Number
- 2124215-2013-11170
- Event Type
- Injury
- Date Received
- July 22, 2013
- Date of Event
- May 17, 2013
- Report Date
- May 17, 2013
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION REVEALED DRIED BLOOD/BLOODY FLUID IN THE LEAD LUMEN. ALLEGATION OF DIAPHRAGMATIC STIMULATION AND DISLODGEMENT NOT CONFIRMED VISUALLY.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THAT THIS LEFT VENTRICULAR (LV) LEAD HAD DISLODGED LITTLE WHICH PROBABLY CAUSED THE DIAPHRAGMATIC STIMULATION THAT THE PATIENT HAS BEEN FEELING. THIS LEAD WAS EXPLANTED AND RETURNED. ADDITIONAL INFORMATION RECEIVED CONFIRMING THE MUSCLE STIMULATION IN ALL CONFIGURATION BROUGHT ABOUT BY MICRODISLODGEMENT OF THE LV LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340970 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Hospitalization| L| R | 4136| 4137| V173| 4555| 4543 |