MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-18 for ELECTROPHYSIOLOGY (FIXED) manufactured by St. Jude Medical, Inc..
[65207844]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[65207905]
Related manufacturer reference 3005334138-2017-00004. Following an atrioventricular nodal reentry tachycardia ablation procedure, a pericardial effusion occurred. Following the procedure, the patient became hypotensive and an echocardiogram was performed which revealed a pericardial effusion on the right side of the patient's heart. A pericardiocentesis was performed which stabilized the patient. There were no performance issues with any sjm devices.
Patient Sequence No: 1, Text Type: D, B5
[66010995]
The results of the investigation are inconclusive since the device was not returned for analysis. A review of the device history record was not possible since the batch number was unavailable. Based on the information received, the cause of the reported pericardial effusion could not be conclusively determined. Per the ifu, cardiac perforation is a known risk during the use of this device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182269-2017-00009 |
| MDR Report Key | 6262580 |
| Date Received | 2017-01-18 |
| Date of Report | 2016-12-19 |
| Date of Event | 2016-12-19 |
| Date Mfgr Received | 2016-12-19 |
| Date Added to Maude | 2017-01-18 |
| 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 | 14901 DEVEAU PLACE |
| Manufacturer City | MINNETONKA MN 55345 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55345 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTROPHYSIOLOGY (FIXED) |
| Generic Name | ELECTROPHYSIOLOGY (FIXED) |
| Product Code | MTE |
| Date Received | 2017-01-18 |
| 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 | 14901 DEVEAU PLACE MINNETONKA MN 55345 US 55345 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-01-18 |