FDA Adverse Event
Injury
Summary report: N
INCEPTA
MDR report key: 2780551
·
Received October 10, 2012
Report
- Report Number
- 2124215-2012-12943
- Event Type
- Injury
- Date Received
- October 10, 2012
- Date of Event
- September 19, 2012
- Report Date
- September 19, 2012
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS SUCCESSFULLY IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE PROCEDURE TO IMPLANT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), NOISE WAS OBSERVED WHICH WAS OVERSENSED AND RESULTED IN PACING INHIBITION FOR THIS PATIENT. THE CLINICAL OBSERVATIONS WERE SUSPECTED TO BE THE RESULT OF AIR BUBBLES IN THE DEVICE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INCEPTA | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | N160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| L |