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 2017-11-02 for WORKMATE? CLARIS? EP-4? CARDIAC STIMULATOR H403023 manufactured by St. Jude Medical, Inc..
[91335691]
During a procedure, the ep-4 would not communicate with the computer or the touchscreen. When pacing could not be performed, a loop recorder was implanted. The procedure was cancelled.
Patient Sequence No: 1, Text Type: D, B5
[117876336]
When pacing could not be performed, a loop recorder was implanted instead.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184149-2017-00039 |
| MDR Report Key | 6996739 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-11-02 |
| Date of Report | 2017-12-14 |
| Date of Event | 2017-09-26 |
| Date Mfgr Received | 2017-12-08 |
| Device Manufacturer Date | 2016-03-29 |
| Date Added to Maude | 2017-11-02 |
| 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. (AF-ST. PAUL) |
| 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 | 2017-11-02 |
| Returned To Mfg | 2017-09-07 |
| Model Number | H403023 |
| Lot Number | 5355536 |
| 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 | 2017-11-02 |