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 2017-08-29 for EP-WORKMATE? SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL 09-1463-0120 manufactured by St. Jude Medical, Inc..
[83869939]
When the amplifier was booting it gave only one tone and would not communicate with the workstation. The procedure was abandoned and there were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[108386893]
Based on the information provided to abbott and the investigation performed, the root cause of the reported event was isolated to abnormal functionality of the single board computer pca. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed. The review determined the process was performed and completed in accordance with abbott specifications and procedures.
Patient Sequence No: 1, Text Type: N, H10
[108386897]
When the amplifier was booting up it gave only one tone and would not communicate with the workstation. The paroxysmal supraventricular tachycardia (psvt) ablation procedure was cancelled and there were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184149-2017-00024 |
| MDR Report Key | 6826991 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-08-29 |
| Date of Report | 2017-10-03 |
| Date of Event | 2017-08-15 |
| Date Mfgr Received | 2017-09-22 |
| Device Manufacturer Date | 2007-11-02 |
| Date Added to Maude | 2017-08-29 |
| 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? SCU-SIGNAL CONDITIONING UNIT (AMPLIFIER), 120 CHANNEL |
| Generic Name | EXTERNAL PROGRAMMABLE PACEMAKER PULSE GENERATOR |
| Product Code | JOQ |
| Date Received | 2017-08-29 |
| Model Number | 09-1463-0120 |
| 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 | ONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-29 |