FDA Adverse Event
Malfunction
Summary report: N
COMPUPACE PACING SYSTEM
MDR report key: 44183
·
Received October 18, 1996
Report
- Report Number
- 1640319-1996-00449
- Event Type
- Malfunction
- Date Received
- October 18, 1996
- Date of Event
- August 27, 1996
- Report Date
- October 18, 1996
- Manufacturer
- INTERMEDICS, INC.
- Product Code
- KRE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: THE DEVICE WAS SUBJECTED TO ELECTRICAL/MECHANICAL FUNCTION TESTING AND A COMPLETE VISUAL INSPECTION. NORMAL OPERATION WAS OBSERVED.
Description of Event or Problem · 1
THE REPORTER INDICATED THAT A CURRENT OF .07 -0.8 MA AND A LEAD IMPEDANCE OF 7000 OHMS OR HIGHER ARE DISPLAYED WITHOUT CONNECTING THE PSC CABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPUPACE PACING SYSTEM | ANALYZER | KRE | INTERMEDICS, INC. | 52401 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |