FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 2173667
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10742
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 23, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Additional Manufacturer Narrative · 1
THESE PRODUCTS WERE RETURNED AND A RETURN REQUEST WAS MADE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER, ATRIAL, RIGHT VENTRICULAR LEADS WERE TO BE EXPLANTED DUE TO A PATIENT INFECTION. THE PATIENT WAS HOSPITALIZED AND TREATED WITH ANTIBIOTICS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALTRUA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | S203 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention | S203| 4087| 4088 |