FDA Adverse Event
Malfunction
Summary report: N
VENTAK PRIZM 2 DR
MDR report key: 543962
·
Received August 10, 2004
Report
- Report Number
- 2124215-2004-07952
- Event Type
- Malfunction
- Date Received
- August 10, 2004
- Date of Event
- May 3, 2004
- Report Date
- May 3, 2004
- Manufacturer
- CARDIAC PACEMAKERS, INC
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND ASSOCIATED IMPLANTABLE TRANSVENOUS DEFIBRILLATION LEAD EXHIBITED A SHOCK LEAD IMPEDANCE TEST (LIT) > 125 OHMS ON NOVEMBER 3, 2003. ON NOVEMBER 18, 2003 A NON-INVASIVE PERIPHERAL STIMULATION (NIPS) PROCEDURE WAS PERFORMED AND THE SHOCKING LEAD IMPEDANCE MEASURED 54 OHMS. DURING FOLLOW-UP IN MAY 2004, THE (LIT) MEASURED 84 AND > 125 OHMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VENTAK PRIZM 2 DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | CARDIAC PACEMAKERS, INC | 1861 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Other | THE DEVICE 4087/156415 WAS IMPLANTED 24-JAN-2003| THE DEVICE 0158/109243 WAS IMPLANTED 24-JAN-2003 |