NAIDA CI Q70 CI-5245-140

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-15 for NAIDA CI Q70 CI-5245-140 manufactured by Advanced Bionics.

Event Text Entries

[83096496] Cochlear implant surgery (b)(6) 2013. Processor early (b)(6) 2013. Advanced bionics' man component, their processor, kept failing. There was a three yr warranty on it and they gave it one more year (voluntary). I pursued the issues in 2015 (and due to my own issues forgot until 2017 when i explored it all again). Processor failure return to ab dates: (b)(6) 2014, (b)(6) 2015, (b)(6) 2017 - last not returned yet. Audiologist had to figure out a way to get the processor without me giving up mine. Longer story - working around ab. Cable "cut off" after 3 months. On (b)(6) 2015; 2015 using paperclip to hold (b)(6) clip together. It's 2017 and still holding, but a fixed clip would be better. Had major sore behind ear. Magnet (had two) stopped holding. (not ab's problem and not in the spreadsheet. ) on (b)(6) 2015; put lithium battery (had 675 powercells batteries prior). First time in within 24 hours with lithium battery, it stopped working. On (b)(6) 2015; t-mic obviously bent and broken. (b)(6) emailed with a picture of it likely my problem. On (b)(6) 2015; (b)(6) - totally drained lithium battery (let it beep down until it died). Put it on the charger. Blue going on and within 30 mins, became green (abnormal). Left it on all night (b)(6) 2015. Used the fully charged same lithium battery (b)(6) and it started beeping the countdown to being drained. It never did this before, but it's cutting sound like crazy. On (b)(6) 2015; i added 2 more magnets that was bad. Reduced to 3 and padded it, my idea. This stopped the sores. Not ab's problem and not in spreadsheet. On (b)(6) 2016; the cable on (b)(6) 2015 "shorted out" by (b)(6) 2016. It was less than 3 months old. I asked (b)(6) what can i do to fix it. He said send the processor back. I started wondering if parts stopped working, ab took a guess as to what happened. On (b)(6) 2016; if it happens gain. As usual (and i get he's low in the totem pole but it's annoying). I looped (b)(6) early in on thursday, and asked her. No response yet. Three days (didn't matter if there was a response or not and i may have missed it. ) on (b)(6) 2016; (b)(6) 2017; 2017 ab will put vanderbilt's prog. , in it. I'll have to go back for mapping (or skip it - beyond tired and tinnitus is spiking. ). On (b)(6) 2017 (b)(6) audiologist - sw a modification level behind i understand and the email sounded like an excuse from ab. Couldn't use it to remap. Wasted trip again but not due to jc. Also, never heard from ab as to why last proc. , lasted 1. 5 yrs. They have the info and were supposed to get back to me. Received email from ab audiologist but to two of us, it blamed me and didn't make sense. On (b)(6) 2015, pin on clip slipped again, but i was able to fix it because it was only partially out. Problem, my eyesight is getting worse and may not be able to do this again. On (b)(6) 2015 rf cable died after 7. 5 months. Longer is only one i can use. I voluntarily (not asked) sent the smaller cable back. Since long cable is still under warranty, opted to get a replacement, safer that way. On (b)(6) 2015; processor turned solid red. Emailed (b)(6) immediately and somewhat angrily. Summarized what i've done and what i'm doing to test other combinations. I was told in an email in (b)(6) 2017 all the processors i returned would be checked (that's my interpretation). I said i would not buy their insurance until i knew why their processor failure was so high. I'm guessing they'll never tell me what happened. Cochlear implant but taking precautions to not have it fail again. I can't wear it all the time (as designed) since i'm afraid of failure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5071605
MDR Report Key6800096
Date Received2017-08-15
Date of Report2017-08-15
Date of Event2014-10-16
Date Added to Maude2017-08-17
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 0

Brand NameNAIDA CI Q70
Generic NameIMPLANTS COCHLEAR
Product CodeESD
Date Received2017-08-15
Model NumberCI-5245-140
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No0
Device Event Key0
ManufacturerADVANCED BIONICS

Device Sequence Number: 1

Brand NameNAIDA CI Q70
Generic NameIMPLANTS COCHLEAR
Product CodeESD
Date Received2017-08-15
Model NumberCI-5245-140
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.