MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM MI1250 SYNCHRONY 2 36705 manufactured by Med-el Elektromedizinische Geraete Gmbh.
[186273981]
Around one month after implantation surgery the recipient developed fever and was feeling sick, was tested for the flu but then recovered. On the (b)(6) 2020 the same symptoms occurred, sickness and high fever. The user was admitted to hospital and diagnosed with meningitis, then recovered and was released on (b)(6). The device has not been worn since being admitted to hospital. Due to the re-occurrence of meningitis, the user was explanted on the (b)(6) 2020. This report refers to 9710014-2020-00192. For further information please refer to this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1066702-2020-00025 |
| MDR Report Key | 9887442 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-05 |
| Date Facility Aware | 2020-03-19 |
| Report Date | 2020-03-20 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM |
| Generic Name | COCHLEAR IMPLANT |
| Product Code | MCM |
| Date Received | 2020-03-27 |
| Model Number | MI1250 SYNCHRONY 2 |
| Catalog Number | 36705 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH |
| Manufacturer Address | INNSBRUCK AU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-27 |