MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-02 for HF SENSOR DELIVERY SYSTEM CM2000 manufactured by St. Jude Medical, Inc..
[181632777]
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Patient Sequence No: 1, Text Type: N, H10
[181632778]
On (b)(6) 2020 a right heart catheterization was performed to confirm the validity of the pressure sensor readings. The sensor was recalibrated on (b)(6) 2020, and the mean was increased by 20mmhg. Accurate readings were observed under the manufacturer's patient care network database.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2020-00109 |
| MDR Report Key | 9775611 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-02 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2015-07-16 |
| Date Added to Maude | 2020-03-02 |
| 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 | 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. |
| 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 | 2020-03-02 |
| Model Number | CM2000 |
| Catalog Number | CM2000 |
| Lot Number | 5176810 |
| Device Expiration Date | 2017-07-16 |
| 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 | 387 TECHNOLOGY CIRCLE NW SUITE 500 ATLANTA GA 30313 US 30313 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-02 |