FDA Adverse Event
Malfunction
Summary report: N
INCEPTA
MDR report key: 4132314
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-14958
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- May 16, 2014
- Report Date
- July 21, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE PATIENT WILL CONTINUE TO BE MONITORED. 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 FOLLOWING THE IMPLANT OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), NOISE WAS OVERSENSED RESULTING IN AN INAPPROPRIATE SHOCK. THERE WAS NO NOISE PRESENT DURING THE PROCEDURE AND ONLY ONE EPISODE WAS STORED. THE ELECTROGRAM (EGM) WAS REVIEWED AND IT WAS CONSISTENT WITH AIR BUBBLES IN THE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612193 | INCEPTA | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWP | GUIDANT CRM CLONMEL IRELAND | N161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | N161| 4554| 0175| T135| 5076 |