FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 2161294
·
Received July 13, 2011
Report
- Report Number
- 2124215-2011-07098
- Event Type
- Injury
- Date Received
- July 13, 2011
- Date of Event
- April 14, 2011
- Report Date
- April 14, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE AVAILABLE INFORMATION SUGGESTS THIS PRODUCT REMAINS IN SERVICE. 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 THE PATIENT IMPLANTED WITH THIS PRODUCT DEVELOPED AN INFECTION FOLLOWING A NORMAL DEVICE REPLACEMENT PROCEDURE. THE PATIENT SELF TREATED THE INFECTION WITH OVER THE COUNTER MEDICATION AND TALC POWDER, WHICH RESOLVED THE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRUA | NVZ | GUIDANT CRM CLONMEL IRELAND | S404 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Life Threatening | 4086| 1276| S404| 4087 |