MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-27 for ACQMAP? 3D IMAGING AND MAPPING CATHETER 900003 manufactured by Acutus Medical, Inc..
| Report Number | 3012120746-2020-00003 |
| MDR Report Key | 9766175 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-02-13 |
| Device Manufacturer Date | 2019-10-23 |
| Date Added to Maude | 2020-02-27 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KAREN KINCADE |
| Manufacturer Street | 2210 FARADAY AVENUE SUITE 100 |
| Manufacturer City | CARLSBAD, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 2326123 |
| Manufacturer G1 | ACUTUS MEDICAL, INC. |
| Manufacturer Street | 2210 FARADAY AVENUE SUITE 100 |
| Manufacturer City | CARLSBAD, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACQMAP? 3D IMAGING AND MAPPING CATHETER |
| Generic Name | CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY |
| Product Code | MTD |
| Date Received | 2020-02-27 |
| Model Number | 900003 |
| Catalog Number | 900003 |
| Lot Number | 100317 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ACUTUS MEDICAL, INC. |
| Manufacturer Address | 2210 FARADAY AVENUE SUITE 100 CARLSBAD, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2020-02-27 |