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 2019-04-05 for EP-WORKMATE? AND WORKMATE? CLARIS? EP-4? TOUCHSCREEN COMPUTER H21911 manufactured by St. Jude Medical, Inc..
[141042353]
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.?
Patient Sequence No: 1, Text Type: N, H10
[141042354]
Related manufacturing ref: 2184149-2019-00040. Near the end of a premature ventricular contraction (pvc) procedure, the touchscreen computer delivered six stimuli to the patient instead of three and induced ventricular fibrillation. The patient went into ventricular fibrillation and cardioversion was required to stabilize the patient. The procedure was completed successfully and the patient is in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184149-2019-00039 |
| MDR Report Key | 8487017 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-05 |
| Date of Report | 2019-05-17 |
| Date of Event | 2019-03-12 |
| Date Mfgr Received | 2019-05-16 |
| Device Manufacturer Date | 2012-09-27 |
| Date Added to Maude | 2019-04-05 |
| 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 | 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 | EP-WORKMATE? AND WORKMATE? CLARIS? EP-4? TOUCHSCREEN COMPUTER |
| Generic Name | GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE |
| Product Code | JOQ |
| Date Received | 2019-04-05 |
| Returned To Mfg | 2019-05-15 |
| Model Number | H21911 |
| Catalog Number | H21911 |
| Lot Number | 6101386 |
| 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. Required No Informationntervention | 2019-04-05 |