FDA Adverse Event
Injury
Summary report: N
EASYTRAK 2
MDR report key: 2153312
·
Received July 7, 2011
Report
- Report Number
- 2124215-2011-06275
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 7, 2011
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- OJX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE EXPLANTED LEAD WAS DISCARDED THUS WILL NOT BE RETURNED FOR A POST MARKET ASSESSMENT. IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCES AND LOSS OF CAPTURE, DURING A ROUTINE CLINICAL FOLLOW-UP. AN X-RAY WAS PERFORMED CONFIRMING A LEAD FRACTURE UNDER THE CLAVICLE. WHILE NO ADVERSE PATIENT EFFECTS WERE REPORTED THE LEAD WAS SURGICALLY EXPLANTED AND ANOTHER LEAD IMPLANTED IN THE ABSENCE OF COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | GUIDANT PUERTO RICO BV | 4517 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |