FDA Adverse Event
Malfunction
Summary report: N
ENERGEN
MDR report key: 3212458
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-08554
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- March 23, 2013
- Report Date
- May 23, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- 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 THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A LOW, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE REPORTED THAT THE SYSTEM DISPLAYED ONLY ONE OUT OF RANGE MEASUREMENT. THE PHYSICIAN ELECTED TO MONITOR THE SYSTEM VIA THE PATIENT'S HOME REMOTE MONITORING SYSTEM. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312023 | ENERGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E143 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | T167| E143| 4037| 4480| 1861| 0154 |