MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-10-05 for PRUKA CARDIOLAB CLAB AMPLIFIER * manufactured by Ge Marquette.
[16031145]
Amplifier pacing channel failed during implantation of dual chamber pacemaker necessitating bypassing amplifier & using direct stimulatiion. Facility was using a leaner amplifier because facility had several problems with their product and facility's amplifier was being fired. Pt was not injured because of very quick action of md/technician but the potential for pt injury/death was present.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 300214 |
| MDR Report Key | 300214 |
| Date Received | 2000-10-05 |
| Date of Report | 2000-09-13 |
| Date of Event | 2000-09-06 |
| Date Facility Aware | 2000-09-06 |
| Report Date | 2000-09-13 |
| Date Reported to FDA | 2000-09-13 |
| Date Reported to Mfgr | 2000-09-14 |
| Date Added to Maude | 2000-10-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRUKA CARDIOLAB |
| Generic Name | AMPLIFIER MODEL-CLAB SNCA1316 |
| Product Code | DRR |
| Date Received | 2000-10-05 |
| Returned To Mfg | 2000-09-08 |
| Model Number | CLAB AMPLIFIER |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 287008 |
| Manufacturer | GE MARQUETTE |
| Manufacturer Address | 100 MARQUETTE DR JUPITER FL 33458 US |
| Baseline Brand Name | CARDIOLAB AMPLIFIER |
| Baseline Generic Name | AMPLIFIER |
| Baseline Model No | 210-00226-00 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | CARDIOLAB AMPLIFIER |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K001305 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2000-10-05 |