MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-27 for CARDIOMEMS PATIENT ELECTRONICS SYSTEM CM1000 manufactured by St. Jude Medical, Inc. - Cardiomems.
[185479075]
The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[185479076]
Related mfr report numbers 3004936110-2020-00156; 3004936110-2016-00033; 3004936110-2017-00163. Remote monitoring of chronic heart failure patients: invasive versus non-invasive tools for optimising patient management , author: veenis, j f 1 ; brugts, j j 1. Publication info: netherlands heart journal : monthly journal of the netherlands society of cardiology and the netherlands heart foundation 28. 1: 3-13. (jan 2020). Per the article: "the recent us post approval study (pas) reported a device- or system-related complication in 0. 3% of all patients (4 out of 1214), and a sensor failure in only 0. 1% of all patients (1 out of 1200), which confirms the safety and durability of this technique. " the data below was also provided to the fda via the " cardiomems hf system post-approval study annual (2019) progress report. The event being reported is as follows: one event involved an unsuccessful implantation procedure in which wire access to the pulmonary artery branch was lost during device placement, resulting in removal of the device and reinsertion of the swan-ganz catheter and balloon inflation for angiogram. The angiogram revealed that a small pulmonary artery was entered by the swan-ganz catheter during re-insertion and inflation, resulting in rupture of a small branch of the pulmonary artery and a pulmonary hemorrhage. The hemorrhage was successfully controlled using a balloon and coils. However, due to religious beliefs, the subject refused blood products following the event and died five days following the event. Further information was requested but not received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2020-00157 |
| MDR Report Key | 9891724 |
| Report Source | LITERATURE |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-27 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE N |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC. - CARDIOMEMS |
| Manufacturer Street | 387 TECHNOLOGY CIRCLE NW SUITE 500 |
| Manufacturer City | ATLANTA GA 30313 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30313 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOMEMS PATIENT ELECTRONICS SYSTEM |
| Generic Name | SYSTEM, HEMODYNAMIC, IMPLANTABLE |
| Product Code | MOM |
| Date Received | 2020-03-27 |
| Model Number | CM1000 |
| Catalog Number | CM1000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC. - CARDIOMEMS |
| Manufacturer Address | 387 TECHNOLOGY CIRCLE NW SUITE 500 ATLANTA GA 30313 US 30313 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-27 |