MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for CONFIRM DM3500 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[185714857]
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
[185714858]
It was reported that an error message was displayed. Telemetry break is encountered while the test is ongoing. A sense amplitude test was ongoing, and it was aborted due to channel closure, then a text? An atypical condition detected by the device? Was displayed for failure reason. The device remains implanted. The patient was stable before, during and the after the event.
Patient Sequence No: 1, Text Type: D, B5
[188442182]
Please retract this report 2938836-2020-02331, as the serial number was unknown and has been identified as (b)(4) and the issue was previously reported as 2938836-2020-01801.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2938836-2020-02331 |
| MDR Report Key | 9901988 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-04-03 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-24 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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-SUNNYVALE) |
| Manufacturer Street | 645 ALMANOR AVENUE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| 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 | 2020-03-31 |
| Model Number | DM3500 |
| Catalog Number | DM3500 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
| Manufacturer Address | 645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |