MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2012-11-02 for EP-4 STIMULATOR, 4 CHANNEL 09-1527-0000 manufactured by St. Jude Medical, Inc. (af-st. Paul).
[2935806]
It was reported during an electrophysiology procedure, while pacing the patient with the ep4 stimulator, the cycle length was changed by the user from 280 ms to 270 ms when the user noted a pacing impulse was inappropriately delivered 120 ms after the previously paced beat. The recording system displayed no capture from the impulse delivered but a pacing spike was noted. The system then began pacing at 270 ms as programmed by the user and the procedure continued with no consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[10265959]
The case study has not been received for analysis. Upon receipt and completion of the failure analysis of the case study, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184149-2012-00032 |
| MDR Report Key | 2822788 |
| Report Source | 05,07 |
| Date Received | 2012-11-02 |
| Date of Report | 2012-10-12 |
| Date of Event | 2012-10-12 |
| Date Mfgr Received | 2012-10-12 |
| Date Added to Maude | 2012-12-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DENISE JOHNSON, RN |
| Manufacturer Street | 177 EAST COUNTRY RD. B |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal | 55117 |
| Manufacturer Phone | 6517564071 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EP-4 STIMULATOR, 4 CHANNEL |
| Generic Name | EXTERNAL PROGRAMMABLE PACEMAKER PULSE GE |
| Product Code | JOQ |
| Date Received | 2012-11-02 |
| Model Number | 09-1527-0000 |
| 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. (AF-ST. PAUL) |
| Manufacturer Address | ST. PAUL MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-02 |