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 2017-12-14 for WORKMATE? CLARIS? EP-4? CARDIAC STIMULATOR H403023 manufactured by St. Jude Medical, Inc..
[94898299]
During a procedure, the stimulator was not responding. All connections were checked and attempts were made to connect the touchscreen directly to the pc but the issue remained. The procedure was cancelled and there were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[109554658]
Conclusion code: no conclusion code available. The stimulator was received for analysis and the reported event of a communication issue was confirmed. It was also confirmed that the stimulator failed to successfully execute the post (power on self-test) and communicate with the ep-4 touchscreen pc, which confirmed the reported issue. Testing isolated the single board computer as the root cause of the communication issue. 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 | 2184149-2017-00074 |
| MDR Report Key | 7118976 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-14 |
| Date of Report | 2018-01-05 |
| Date of Event | 2017-10-16 |
| Date Mfgr Received | 2018-01-03 |
| Device Manufacturer Date | 2017-08-15 |
| Date Added to Maude | 2017-12-14 |
| 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 | 2017-12-14 |
| Returned To Mfg | 2018-01-02 |
| Model Number | H403023 |
| Lot Number | 6071383 |
| ID Number | 05414734030236 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-12-14 |