FDA Adverse Event
Malfunction
Summary report: N
EASYTRAK 2
MDR report key: 2780169
·
Received October 10, 2012
Report
- Report Number
- 2124215-2012-12369
- Event Type
- Malfunction
- Date Received
- October 10, 2012
- Date of Event
- September 1, 2012
- Report Date
- September 1, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- OJX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEFT VENTRICULAR LEAD DISPLAYED PACING IMPEDANCES GREATER THAN 2000 OHMS VIA RECENT LATITUDE TRANSMISSIONS. ADDITIONALLY, VARIABLE LV INTRINSIC AMPLITUDES WERE NOTED. A FOLLOW-UP TO ASSESS THE LEAD IS SCHEDULED FOR THE NEAR FUTURE, HOWEVER NO REMEDIAL ACTION HAS YET BEEN TAKEN AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EASYTRAK 2 | IMPLANTABLE LEAD | OJX | CPI - DEL CARIBE | 4543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | N119| 4136| 4471| 0186| 4543| 4555 |