FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 2151426
·
Received July 6, 2011
Report
- Report Number
- 2124215-2011-06358
- Event Type
- Injury
- Date Received
- July 6, 2011
- Date of Event
- February 18, 2011
- Report Date
- April 5, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE HAS BEEN HOSPITALIZED SINCE (B)(6) POST IMPLANT, DUE TO A MASSIVE RIGHT ISCHEMIC STROKE, DIAGNOSED VIA A BRAIN COMPUTED TOMOGRAPHY (CT) SCAN. THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) EXHIBITED A LEFT ATRIAL THROMBUS AND THE POSSIBILITY OF A RIGHT ATRIAL THROMBUS. NO FURTHER INFORMATION HAS BEEN COMMUNICATED; PATIENT REMAINS HOSPITALIZED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRUA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | S601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L |