FDA Adverse Event
Malfunction
Summary report: N
VITALITY 2 DR
MDR report key: 710360
·
Received May 9, 2006
Report
- Report Number
- 2124215-2006-14339
- Event Type
- Malfunction
- Date Received
- May 9, 2006
- Date of Event
- March 21, 2006
- Report Date
- March 21, 2006
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD RECEIVED FIVE SHOCKS THAT DID NOT CONVERT THE PATIENT'S RHYTHM. THE SHOCK LEAD IMPEDANCE MEASUREMENT DURING THIS TIME REVEALED A LESS THAN 20 OHMS READING. A SIXTH SHOCK WAS DELIVERED AND SUCCESSFULLY CONVERTED THE PATIENT. HOWEVER, AN ERROR MESSAGE WAS THEN RECEIVED STATING THAT THERE WAS A 'SHORTED CIRCUIT' DURING THE INTERROGATION. THE VENTRICULAR PACING IMPEDANCE WAS NOTED TO BE GREATER THAN 4000 OHMS. THE DEVICE WAS EXPLANTED AND THE DEFIBRILLATION LEAD CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VITALITY 2 DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | T165 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |