FDA Adverse Event
Malfunction
Summary report: N
ENERGEN
MDR report key: 3043225
·
Received April 9, 2013
Report
- Report Number
- 2124215-2013-02145
- Event Type
- Malfunction
- Date Received
- April 9, 2013
- Date of Event
- January 19, 2013
- Report Date
- October 27, 2013
- Manufacturer
- GUIDANT CRM CLONMEL IRELAND
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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
ADDITIONAL INFORMATION WAS RECEIVED THAT THE DEVICE CONTINUED TO EXHIBIT HIGH SHOCK LEAD IMPEDANCE MEASUREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IN SERVICE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CAUSED A RED ALERT TO BE DECLARED DUE TO HIGH SHOCK IMPEDANCES. THE PATIENT'S PHYSICIAN IS AWARE OF THE SITUATION AND THE PACING SYSTEM REMAINS IMPLANTED AT THIS TIME (THE RIGHT VENTRICULAR (RV) LEAD MODEL AND SERIAL NUMBER ARE UNKNOWN) NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145168 | ENERGEN | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | GUIDANT CRM CLONMEL IRELAND | P142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |