FDA Adverse Event
Injury
Summary report: N
CONTAK RENEWAL
MDR report key: 2163428
·
Received July 15, 2011
Report
- Report Number
- 2124215-2011-07363
- Event Type
- Injury
- Date Received
- July 15, 2011
- Date of Event
- April 21, 2011
- Report Date
- April 21, 2011
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- NIK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL
- 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.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION AND EROSION. ADDITIONALLY, DURING THE REMOVAL OF THE SYSTEM, THE PATIENT EXPERIENCED A PERICARDIAL EFFUSION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM, AND IT WAS NOTICED THE RIGHT VENTRICLE HAD BEEN PERFORATED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONTAK RENEWAL | IMPLANTABLE CHF GENERATOR | NIK | GUIDANT CRM CLONMEL IRELAND | H210 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| L| R | (B)(4)| (B)(4)| (B)(4)| (B)(4) |