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 2020-03-30 for FORTIFY ASSURA DR ICD, US CD2357-40C manufactured by St. Jude Medical, Inc.(crm-sylmar).
[185697692]
The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[185697693]
It was reported that the implantable cardioverter defibrillator exhibited intermittent non-sustained ventricular over-sensing events which occurred on (b)(6) 2020 and (b)(6) 2020. It was noted that the over-sensing events were due to crosstalk or sensing of the atrial pace on the ventricular channel. Programming changes were discussed. No interventions were made at this time. There were no consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2020-04437 |
| MDR Report Key | 9901609 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-02-23 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2016-12-07 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORTIFY ASSURA DR ICD, US |
| Generic Name | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
| Product Code | NVZ |
| Date Received | 2020-03-30 |
| Model Number | CD2357-40C |
| Catalog Number | CD2357-40C |
| Lot Number | A000032887 |
| Device Expiration Date | 2018-12-31 |
| 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 | 2020-03-30 |