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 2017-12-06 for EP-WORKMATE? EP-4? CARDIAC STIMULATOR, 4 CHANNEL 09-1527-0000 manufactured by St. Jude Medical, Inc..
[93839829]
During a procedure, the stimulator was not able to communicate with the touchscreen. The procedure was cancelled. There were no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
[108382827]
No conclusion code available. Based on the information provided to abbott and the investigation performed, the root cause of the reported communication issue was isolated to abnormal functionality of the single board computer. Ac power was applied to the ep-4 stimulator which failed to successfully execute the power on self-test or establish communication with the touchscreen computer. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2017-00067 |
| MDR Report Key | 7086516 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-06 |
| Date of Report | 2018-01-16 |
| Date of Event | 2017-11-06 |
| Date Mfgr Received | 2017-12-22 |
| Date Added to Maude | 2017-12-06 |
| 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 | DENISE JOHNSON |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517564470 |
| 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? EP-4? CARDIAC STIMULATOR, 4 CHANNEL |
| Generic Name | GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE |
| Product Code | JOQ |
| Date Received | 2017-12-06 |
| Returned To Mfg | 2017-12-20 |
| Model Number | 09-1527-0000 |
| ID Number | 05414734030236 |
| 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 | 2017-12-06 |