FDA Adverse Event
Malfunction
Summary report: N
TELIGEN
MDR report key: 3771416
·
Received April 24, 2014
Report
- Report Number
- 2124215-2014-09213
- Event Type
- Malfunction
- Date Received
- April 24, 2014
- Date of Event
- February 19, 2012
- Report Date
- February 20, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- PMA / PMN Number
- P960040
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING HIGH PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THERE WAS NO EVIDENCE OF NOISE ON THE RV LEAD. THE PRESENTING ELECTROGRAM (EGM) INDICATED INTRINSIC ATRIAL SENSING WITH VENTRICULAR PACING MARKERS. THE MORPHOLOGY ON THE SHOCK CHANNEL INDICATED APPROPRIATE CAPTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248537 | TELIGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWP | GUIDANT CRM CLONMEL IRELAND | E110 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | E110| 4470| 0175 |