FDA Adverse Event
Injury
Summary report: N
INSIGNIA
MDR report key: 2170949
·
Received July 21, 2011
Report
- Report Number
- 2124215-2011-11155
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- January 21, 2009
- Report Date
- June 6, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
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 THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE. ALTHOUGH THIS WAS EXPLANTED IN 2009, A BOSTON SCIENTIFIC EMPLOYEE FIRST RECEIVED NOTIFICATION OF THE EVENT VIA WARRANTY INFORMATION IN (B)(4) 2011.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization| L| R | S603| 4470| 4471| 1290 |