FDA Adverse Event
Malfunction
Summary report: N
ENERGEN
MDR report key: 4132221
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-15915
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- May 10, 2014
- Report Date
- July 24, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. THERE WAS A CONCERN THE LV LEAD HAD FRACTURED. THE LEAD WAS REPROGRAMMED TO UNIPOLAR WITH APPROPRIATE SENSING AND CAPTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612558 | ENERGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWP | GUIDANT CRM CLONMEL IRELAND | N141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | H210| N141| 4537| 4136| 4542| 0137 |