FDA Adverse Event
Injury
Summary report: N
INSIGNIA
MDR report key: 2052686
·
Received April 13, 2011
Report
- Report Number
- 2124215-2011-04455
- Event Type
- Injury
- Date Received
- April 13, 2011
- Date of Event
- June 1, 2008
- Report Date
- February 28, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NVZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
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 FROM THE PATIENT'S SON THAT THREE YEARS AGO THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. IT WAS NOTED THAT THE INFECTION ULCERATED THROUGH THE SKIN, AND A SKIN GRAFT HAD TO BE DONE. IT WAS REPLACED WITH A NON-BOSTON SCIENTIFIC PACEMAKER SYSTEM. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGNIA | IMPLANTABLE PULSE GENERATOR | NVZ | GUIDANT CRM CLONMEL IRELAND | 1298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Hospitalization| L| R | 4034| 1298| 4086 |