FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 1946183
·
Received January 4, 2011
Report
- Report Number
- 2124215-2010-20317
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- October 14, 2010
- Report Date
- October 14, 2010
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- 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 THIS PHYSICIAN WILL BE EXTRACTING THIS PACING SYSTEM DUE TO A PATIENT INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRUA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | S603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Life Threatening | 4135| 4136| S603 |