MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-09-14 for NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT N/A manufactured by Cochlear Ltd.
[86078682]
This report is submitted on september 14, 2017, by cochlear limited on behalf of cochlear americas. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[86078683]
Per the clinic, the patient experienced an episode of meningitis within 30 days of implantation (specific date not reported). The patient was hospitalised for a period of 1 week and treated with an iv antibiotic. The patient has since recovered and the device remains implanted. The following additional information was received regarding the episode of meningitis. Etiology of deafness - the patient has no history of cochlear malformation or reported craniofacial malformations. The patient did not received pre-implant immunizations. Perioperative antibiotics (ancef and bacitracin irrigation) were administered. The receiver stimulator was not drilled to the dura and no surgical complications were reported. A csf leak occurred post operatively. The meningitis episode occurred within 30 days of a neurologic procedure. No vp shunts or lumbar drains were utilized at the onset of meningitis. Prior to meningitis, there were no signs of inflammation, fluid in the inner ear, middle ear or mastoid cavity. The patient did not have a prior upper respiratory infection or otitis media prior to meningitis. The patient's csf cultures were positive for klebsiella and pcr analysis also showed klebsiella.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000034-2017-01693 |
| MDR Report Key | 6864057 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-09-14 |
| Date of Report | 2017-08-30 |
| Date Mfgr Received | 2017-08-30 |
| Device Manufacturer Date | 2016-05-04 |
| Date Added to Maude | 2017-09-14 |
| 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 | AUDIOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SUJEEWA WIJESINGHE |
| Manufacturer Street | 1 UNIVERSITY AVENUE |
| Manufacturer City | MACQUARIE UNIVERSITY, NSW 2109 |
| Manufacturer Country | AS |
| Manufacturer Postal | 2109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLEUS ABI541 AUDITORY BRAINSTEM IMPLANT |
| Generic Name | NUCLEUS AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Product Code | MHE |
| Date Received | 2017-09-14 |
| Model Number | ABI541 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Device Expiration Date | 2018-05-04 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COCHLEAR LTD |
| Manufacturer Address | 1 UNIVERSITY AVENUE MACQUARIE UNIVERSITY, NSW 2109 AS 2109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2017-09-14 |