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 2020-02-26 for HF SENSOR DELIVERY SYSTEM CM2000 manufactured by St. Jude Medical, Inc..
[181584945]
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
[181584946]
A right heart catheterization was performed to confirm the validity of the pressure sensor readings. The sensor was recalibrated and the mean was increased by 16. 1 mmhg. Accurate readings were observed under the manufacturer's patient care network database.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004936110-2020-00103 |
| MDR Report Key | 9753044 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Device Manufacturer Date | 2019-04-24 |
| Date Added to Maude | 2020-02-26 |
| 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 | 2020-02-26 |
| Model Number | CM2000 |
| Catalog Number | CM2000 |
| Lot Number | 6965958 |
| 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. |
| Manufacturer Address | 387 TECHNOLOGY CIRCLE NW SUITE 500 ATLANTA GA 30313 US 30313 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-26 |