MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 1996-10-18 for COMPUPACE PACING SYSTEM 52401 * manufactured by Intermedics, Inc..
[27718]
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.
Patient Sequence No: 1, Text Type: D, B5
[21067339]
Evaluation summary: the device was subjected to electrical/mechanical function testing and a complete visual inspection. Normal operation was observed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1640319-1996-00449 |
| MDR Report Key | 44183 |
| Report Source | 08 |
| Date Received | 1996-10-18 |
| Date of Report | 1996-10-18 |
| Date of Event | 1996-08-27 |
| Date Mfgr Received | 1996-09-27 |
| Device Manufacturer Date | 1995-12-01 |
| Date Added to Maude | 1996-10-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPUPACE PACING SYSTEM |
| Generic Name | ANALYZER |
| Product Code | KRE |
| Date Received | 1996-10-18 |
| Returned To Mfg | 1996-10-16 |
| Model Number | 52401 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 45106 |
| Manufacturer | INTERMEDICS, INC. |
| Manufacturer Address | 4000 TECHNOLOGY DR ANGLETON TX 77515 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-10-18 |