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 HF SENSOR DELIVERY SYSTEM CM2000 manufactured by St. Jude Medical, Inc. - Cardiomems.
[186612428]
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
[186612429]
Related mfr report numbers 3004936110-2020-00157; 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 resulting in explant of the device from the pa using a snare, without any complications to the subject. The implant procedure was re-attempted on a subsequent date and completed successfully without any complications. Additional information was requested and is unavailable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2020-00156 |
| MDR Report Key | 9891645 |
| 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 | HF SENSOR DELIVERY SYSTEM |
| Generic Name | SYSTEM, HEMODYNAMIC, IMPLANTABLE |
| Product Code | MOM |
| Date Received | 2020-03-27 |
| Model Number | CM2000 |
| Catalog Number | CM2000 |
| 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. Required No Informationntervention | 2020-03-27 |