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 2018-10-03 for EP-WORKMATE? EP-4? CARDIAC STIMULATOR, 4 CHANNEL 09-1527-0000 manufactured by St. Jude Medical, Inc..
[122617182]
During a procedure a cancellation occurred. During the procedure stimulation channels 2 and 3 were found to not function and the issue could not be resolved. The procedure was cancelled. There were no adverse patient consequences.
Patient Sequence No: 1, Text Type: D, B5
[132624257]
One workmate? Claris? Ep-4? Cardiac stimulator was received into the lab for analysis. The power on self-test and preliminary voltage measurements were performed and confirmed the stimulator passed the internal hardware self-test criteria. It was also confirmed that the stimulator communicated with the ep-4 touchscreen successfully upon self-test completion. The stimulator was then subjected to, and subsequently passed, an extended pacing and memory test without issue. No self-test failures or communication faults were identified throughout testing as the returned stimulator functioned as intended during investigation. 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. Based on the information provided to abbott and the investigation performed, root cause of the field reported cancellation due to non-functioning channels 2 & 3 could not be conclusively determined as no anomalies were identified throughout investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2018-00165 |
| MDR Report Key | 7931802 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-10-03 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-09-04 |
| Date Mfgr Received | 2018-11-27 |
| Device Manufacturer Date | 2011-02-04 |
| Date Added to Maude | 2018-10-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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? EP-4? CARDIAC STIMULATOR, 4 CHANNEL |
| Generic Name | EXTERNAL PROGRAMMABLE PACEMAKER PULSE GENERATOR |
| Product Code | JOQ |
| Date Received | 2018-10-03 |
| Model Number | 09-1527-0000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-10-03 |