MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-20 for PACEL BIPOLAR PACING CATHETER 401771 manufactured by St. Jude Medical.
[175714977]
The results of the investigation are inconclusive since the device was not returned for analysis. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[175714978]
Upon arrival, the patient was exhibiting a myocardial infarction, so a pacing catheter was used. The electrocardiogram monitoring of the patient showed a third-degree atrioventricular block with a heart rate of 34 beats per minute. The catheter was checked and the circuit wire was disconnected at a third of the electrode interface. There was no temporary pacing rhythm. The electrode was replaced, and the electrocardiogram showed ventricular pacing rhythm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182269-2020-00006 |
| MDR Report Key | 9606829 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-20 |
| Date of Event | 2019-10-31 |
| Date Mfgr Received | 2019-12-31 |
| Device Manufacturer Date | 2018-08-07 |
| Date Added to Maude | 2020-01-20 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL |
| Manufacturer Street | 14901 DEVEAU PLACE |
| Manufacturer City | MINNETONKA MN 553452126 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 553452126 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PACEL BIPOLAR PACING CATHETER |
| Generic Name | ELECTRODE, PACEMAKER, TEMPORARY |
| Product Code | LDF |
| Date Received | 2020-01-20 |
| Model Number | 401771 |
| Catalog Number | 401771 |
| Lot Number | 6577145 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 14901 DEVEAU PLACE MINNETONKA MN 553452126 US 553452126 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-20 |