FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 2060060
·
Received April 15, 2011
Report
- Report Number
- 2124215-2011-05793
- Event Type
- Injury
- Date Received
- April 15, 2011
- Date of Event
- March 8, 2011
- Report Date
- March 31, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION IS EXPECTED REGARDING THIS EVENT, OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE MONTH POST IMPLANT, REDNESS WAS NOTED AT THIS PACEMAKER POCKET SITE. A PET SCAN WAS PERFORMED AND ANTIBIOTIC TREATMENT WERE PRESCRIBED. THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.
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 | Other |