FDA Adverse Event
Malfunction
Summary report: N
INCEPTA
MDR report key: 3040699
·
Received April 8, 2013
Report
- Report Number
- 2124215-2013-00659
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- January 8, 2013
- Report Date
- January 8, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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 DURING A ROUTINE DEVICE INTERROGATION, A COMMANDED SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS WAS OBSERVED IN THE TRIAD CONFIGURATION. FOLLOWING A PROGRAMMER UPGRADE, SHOCK IMPEDANCE MEASUREMENTS IN THE TRIAD CONFIGURATION WERE WITHIN ACCEPTABLE LIMITS. NO FURTHER TESTING WAS PERFORMED AND THE DEVICE CURRENTLY REMAINED IN THE TRIAD CONFIGURATION. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THIS CLINICAL OBSERVATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142812 | INCEPTA | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | E161 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | 0185| E161| T175 |