FDA Adverse Event
Injury
Summary report: N
ENERGEN
MDR report key: 2792717
·
Received October 16, 2012
Report
- Report Number
- 2124215-2012-14037
- Event Type
- Injury
- Date Received
- October 16, 2012
- Date of Event
- August 30, 2012
- Report Date
- August 30, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS AVAILABLE, 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 EXPERIENCED A SYNCOPAL EPISODE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE PATIENT'S RECENT HOME MONITORING TRANSMISSION AND NO EVENTS WERE STORED ON THE DATE THE SYNCOPE OCCURRED. A NONSUSTAINED VENTRICULAR TACHYCARDIA DETECTION WAS NOTED A FEW DAYS PRIOR TO THE SYNCOPE AND WAS APPROPRIATELY SENSED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENERGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | N141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Life Threatening | 4542| MISMATCH| N141| 6947 |