FDA Adverse Event
Malfunction
Summary report: N
INTERVENE LEAD
MDR report key: 293808
·
Received August 8, 2000
Report
- Report Number
- 2124215-2000-01857
- Event Type
- Malfunction
- Date Received
- August 8, 2000
- Date of Event
- October 27, 1999
- Report Date
- May 1, 2000
- Manufacturer
- CARDIAC PACEMAKERS
- 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 CPI RECEIVED INFORMATION THAT THE PACE IMPEDANCE MEASUREMENTS WERE HIGH AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT CAPTURING AT MAXIMUM OUTPUT. IT WAS FURTHER REPORTED THAT THE PATIENT FELT MUSCLE STIMULATION A FEW DAYS EARLIER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERVENE LEAD | * | LWS | CARDIAC PACEMAKERS | 497-23 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Other | THE DEVICE 101-/111134 WAS IMPLANTED 27-JAN-1998| THE DEVICE 1790/102782 WAS IMPLANTED 28-OCT-1999 |