MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-26 for CONFIRM DM3500 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[185062366]
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
[185062367]
It was reported that the implantable cardiac monitor exhibited false pauses due to under-sensing. Programming changes were made. There were no patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2020-04199 |
| MDR Report Key | 9883912 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2019-10-27 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2018-07-08 |
| Date Added to Maude | 2020-03-26 |
| 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 | 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 | CONFIRM |
| Generic Name | IMPLANTABLE CARDIAC MONITOR |
| Product Code | MXC |
| Date Received | 2020-03-26 |
| Model Number | DM3500 |
| Catalog Number | DM3500 |
| Lot Number | S000062477 |
| Device Expiration Date | 2019-12-25 |
| 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 | 2020-03-26 |