FDA Adverse Event
Malfunction
Summary report: N
ENERGEN
MDR report key: 3232027
·
Received July 17, 2013
Report
- Report Number
- 2124215-2013-11314
- Event Type
- Malfunction
- Date Received
- July 17, 2013
- Date of Event
- June 2, 2013
- Report Date
- June 2, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
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 PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING MULTIPLE BURSTS OF ANTI-TACHYCARDIA PACING (ATP) AND SIX SHOCKS FOR SINUS TACHYCARDIA WHICH EXHAUSTED THERAPY IN THE VT ZONE. THE PATIENT WAS EXERCISING AT THE TIME THERAPY WAS DELIVERED. THE DEVICE OPERATED AS PROGRAMMED. THE DEVICE SETTINGS WERE REPROGRAMMED FOR OPTIMIZATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331211 | ENERGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E140 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10416 DA | 0296| E140 |