FDA Adverse Event
Injury
Summary report: N
INCEPTA
MDR report key: 3212662
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09146
- Event Type
- Injury
- Date Received
- July 9, 2013
- Date of Event
- May 21, 2013
- Report Date
- May 21, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE REMAINS IN SERVICE. 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 DEVICE WAS PART OF A SYSTEM REVISION DUE TO EROSION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED. THE DEVICE WAS REPOSITIONED TO A SUB-MUSCULAR LOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313071 | INCEPTA | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | F160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L| R |