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 2019-02-07 for IBI? 1400-CV CARDIOVERSION II SWITCH BOX 85432 manufactured by St. Jude Medical, Inc..
[135417632]
During an electrophysiology procedure, a cancellation occurred due to the inability to deliver electric shock. The issue could not be resolved and the procedure was cancelled. There were no adverse patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2030404-2019-00008 |
| MDR Report Key | 8315917 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-07 |
| Date of Report | 2019-04-05 |
| Date of Event | 2019-01-14 |
| Date Mfgr Received | 2019-04-02 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2019-02-07 |
| 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, INC. |
| Manufacturer Street | 2375 MORSE AVE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IBI? 1400-CV CARDIOVERSION II SWITCH BOX |
| Generic Name | SYSTEM, PACING, TEMPORARY, ACUTE, INTERNAL ATRIAL DEFIBRILLATION |
| Product Code | MTE |
| Date Received | 2019-02-07 |
| Model Number | 85432 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | 2375 MORSE AVE IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-07 |