FDA Adverse Event
Malfunction
Summary report: N
INCEPTA
MDR report key: 5370980
·
Received January 15, 2016
Report
- Report Number
- 2124215-2015-14428
- Event Type
- Malfunction
- Date Received
- January 15, 2016
- Date of Event
- October 14, 2015
- Report Date
- October 14, 2015
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE CLINICAL OBSERVATIONS WITH THE CALLER AND TROUBLESHOOTING IDEAS. THE CALLER WILL CONSULT THIS PATIENT'S PHYSICIAN. 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 SYSTEM HAS BEEN EXHIBITING RISING SHOCK IMPEDANCE MEASUREMENTS. MOST RECENTLY, THERE WAS A RED ALERT GENERATED FOR A MEASUREMENT GREATER THAN 125 OHMS AND TODAY, THE MEASUREMENT WAS 133-135 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30389 | INCEPTA | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWP | GUIDANT CRM CLONMEL IRELAND | N160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |