MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-17 for ENSITE VELOCITY? SYSTEM VELOCITY AMPLIFIER 100015555 100014514 manufactured by St. Jude Medical, Inc..
[179700797]
The results/method and conclusion codes along with investigation results will be provided in the final report. Further information regarding the event were requested but not received.
Patient Sequence No: 1, Text Type: N, H10
[179700798]
During a procedure, the amplifier would not boot. The patient was on the table and the procedure was cancelled. The patient was stable and the procedure was rescheduled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184149-2020-00023 |
| MDR Report Key | 9716948 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-17 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2014-06-19 |
| Date Added to Maude | 2020-02-17 |
| 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. (AF-ST. PAUL) |
| Manufacturer Street | ONE ST. JUDE MEDICAL DRIVE |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENSITE VELOCITY? SYSTEM VELOCITY AMPLIFIER |
| Generic Name | COMPUTER, DIAGNOSTIC, PROGRAMMABLE |
| Product Code | DQK |
| Date Received | 2020-02-17 |
| Returned To Mfg | 2020-02-17 |
| Model Number | 100015555 |
| Catalog Number | 100014514 |
| Lot Number | 5371177 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Manufacturer Address | ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-17 |