FDA Adverse Event
Injury
Summary report: N
INCEPTA
MDR report key: 4132220
·
Received October 1, 2014
Report
- Report Number
- 2124215-2014-17626
- Event Type
- Injury
- Date Received
- October 1, 2014
- Date of Event
- July 26, 2014
- Report Date
- July 27, 2014
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWP
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH, OUT-OF-RANGE (OOR), SHOCKING LEAD IMPEDANCE MEASUREMENT OF MORE THAN 125 OHMS. DURING DEVICE CHECK, A MAXIMUM ENERGY SHOCK WAS DELIVERED ON SINGLE COIL CONFIGURATION. ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS. THE PHYSICIAN ELECTED TO MONITOR THE PATIENT REMOTELY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE SYSTEM REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 612086 | INCEPTA | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWP | GUIDANT CRM CLONMEL IRELAND | E161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization| L| R | 0184| T135| E161 |