FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 2052751
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-03573
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- February 25, 2011
- Report Date
- May 26, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, THIS SYSTEM REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE WAS REMOVED. SHOULD FURTHER INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, REDNESS WAS OBSERVED AT THIS PACEMAKER POCKET SITE. THE PATIENT WITH THIS DEVICE WAS HOSPITALIZED, RECEIVED ANTIBIOTIC THERAPY, THE WOUND WAS DEBRIDED AND WILL BE FURTHER MONITORED. 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 | S603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other | 4137| S603| 4136 |