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 Abbott.
[185931884]
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
[185931885]
During follow-up, the diagnostic information from the egms was missing. Technical support recommended sending screenshots of the session records. No intervention was performed to resolve the event and the patient was stable. Further information was requested but not received.
Patient Sequence No: 1, Text Type: D, B5
[186482066]
Additional information: upon review, this product should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused by the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017865-2020-04491 |
| MDR Report Key | 9908147 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-04-01 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-04-01 |
| Device Manufacturer Date | 2018-07-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ABBOTT |
| 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 | 2020-03-31 |
| Model Number | DM3500 |
| Catalog Number | DM3500 |
| Lot Number | S000062430 |
| Device Expiration Date | 2019-12-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |