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 2017-10-27 for WORKMATE? CLARIS? EP-4? CARDIAC STIMULATOR EP-4-04 manufactured by St. Jude Medical, Inc..
[90505426]
During the procedure, the patient developed an arrhythmia. The stimulator would not stop pacing and the ep-4 display screen changed from blue to gray after the pacing was given ten times. Pacing was discontinued by pressing the? Halt? Key. Although the patient developed an arrhythmia while pacing, the procedure was completed successfully.
Patient Sequence No: 1, Text Type: D, B5
[108382377]
The workmate claris computer logs were returned and investigated. A comprehensive review of the events log revealed that the halt key was pressed multiple times on 2 separate occasions near the end of the procedure as reported. The log indicated the halt key was pressed 5 times within a 1 second timeframe; however, based on the information from the events log, the pacing was terminated as stimulation was again initiated shortly after. The results of the basic ep application testing confirmed no abnormal operating symptom or unexpected system behavior during the course of the simulating test study.
Patient Sequence No: 1, Text Type: N, H10
[109556241]
The reported pacing issue was unable to be confirmed. The stimulator was sent to (b)(4) for further investigation. Based on the information provided to abbott, the cause of the issue remains unknown as the issue was not replicated. 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 | 2184149-2017-00029 |
| MDR Report Key | 6985298 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-27 |
| Date of Report | 2018-02-14 |
| Date of Event | 2017-08-22 |
| Date Mfgr Received | 2018-02-09 |
| Device Manufacturer Date | 2016-10-10 |
| Date Added to Maude | 2017-10-27 |
| 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 | WORKMATE? CLARIS? EP-4? CARDIAC STIMULATOR |
| Generic Name | EXTERNAL PROGRAMMABLE PACEMAKER PULSE GENERATOR |
| Product Code | JOQ |
| Date Received | 2017-10-27 |
| Model Number | EP-4-04 |
| Lot Number | 5674924 |
| ID Number | 05414734208741 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Other | 2017-10-27 |