Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K IMPLANT; COCHLEAR IMPLANT
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ADVANCED BIONICS, LLC HIRES 90K IMPLANT; COCHLEAR IMPLANT Back to Search Results
Model Number CI-1400-01
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Ossification (1428); Abscess (1690); Scar Tissue (2060)
Event Date 01/23/2015
Event Type  Injury  
Event Description
The recipient reportedly experienced device migration.The device migrated toward the anterior region.The recipient was advised to discontinue use of the device.The stitch abscess was removed on (b)(6) 2015.The recipient was prescribed augmentin liquid.The recipient was hospitalized on (b)(6) 2015.On (b)(6) 2015, the recipient underwent reposition surgery, due to the scar tissue and new bone formation the recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.The recipient continues to be monitored.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HIRES 90K IMPLANT
Type of Device
COCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
12740 san fernando rd
sylmar CA 91342
Manufacturer Contact
nicole birch, ra associate
12740 san fernando rd
sylmar, CA 91342
6613621528
MDR Report Key4667425
MDR Text Key5687801
Report Number3006556115-2015-00144
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/18/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date04/30/2014
Device Model NumberCI-1400-01
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/25/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/18/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/25/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age3 YR
-
-