MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-03-24 for CONFIRM DM3500 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[184807673]
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
[184807674]
It was reported that the patient was experiencing pain at the implant site of their implantable cardiac monitor. The device was explanted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2020-04058 |
| MDR Report Key | 9874887 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-01-27 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2018-08-13 |
| Date Added to Maude | 2020-03-24 |
| 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 | 2020-03-24 |
| Returned To Mfg | 2020-03-04 |
| Model Number | DM3500 |
| Catalog Number | DM3500 |
| Lot Number | P000066177 |
| Device Expiration Date | 2020-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-24 |