FDA Adverse Event
Injury
Summary report: N
ALTRUA
MDR report key: 2162620
·
Received July 14, 2011
Report
- Report Number
- 2124215-2011-07544
- Event Type
- Injury
- Date Received
- July 14, 2011
- Date of Event
- July 6, 2010
- Report Date
- April 20, 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 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 CONTRACTED AN INFECTION DURING THE IMPLANT PROCEDURE AND COMPLICATIONS DURING THE PATIENT'S STAY AT THE HOSPITAL. THE DEVICE REMAINS IN SERVICE. NO ADDITIONAL 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 | S602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Other | S602| (B)(4)| MISMATCH |