FDA Adverse Event
Injury
Summary report: N
2124215-2011-02952
MDR report key: 2050177
·
Received April 12, 2011
Report
- Report Number
- 2124215-2011-02952
- Event Type
- Injury
- Date Received
- April 12, 2011
- Date of Event
- February 16, 2011
- Report Date
- February 16, 2011
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR REVEALED SIGNS OF EROSION. THE DEVICE MAY BE REPOSITIONED IN THE FUTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LWS | GUIDANT PUERTO RICO BV | TACHY DEVICE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |