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 2020-03-31 for FORTIFY ASSURA DR ICD, US CD2357-40Q manufactured by St. Jude Medical, Inc.(crm-sylmar).
[185942646]
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
[185942647]
Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was explanted. The patient was in stable condition throughout.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2020-04499 |
| MDR Report Key | 9908475 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-27 |
| Date Mfgr Received | 2020-03-27 |
| Device Manufacturer Date | 2014-03-26 |
| Date Added to Maude | 2020-03-31 |
| 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 | ELIZABETH BOLTZ |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0003-2018 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORTIFY ASSURA DR ICD, US |
| Generic Name | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
| Product Code | NVZ |
| Date Received | 2020-03-31 |
| Model Number | CD2357-40Q |
| Catalog Number | CD2357-40Q |
| Lot Number | 4536802 |
| Device Expiration Date | 2016-03-31 |
| 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.(CRM-SYLMAR) |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-31 |