MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-09 for VISIONIST CRT-P U225 manufactured by Boston Scientific Corporation.
[182580871]
As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
Patient Sequence No: 1, Text Type: N, H10
[182580872]
It was reported that the patient with this device was admitted into the intensive care unit due to acute respiratory distress, approximately four days post implant. The patient further deteriorated into a coma and passed away the following day. The physician suspected cardiac and infectious shock, a possible endocarditis case. No return of any product is expected nor received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2020-05111 |
| MDR Report Key | 9806436 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-09 |
| Date of Report | 2020-03-09 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2017-03-07 |
| Date Added to Maude | 2020-03-09 |
| 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 | TIMOTHY DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVENUE NORTH |
| Manufacturer City | SAINT PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VISIONIST CRT-P |
| Generic Name | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) |
| Product Code | NKE |
| Date Received | 2020-03-09 |
| Model Number | U225 |
| Catalog Number | U225 |
| Lot Number | 705033 |
| Device Expiration Date | 2019-02-15 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
| Manufacturer Address | 4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-09 |