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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT; COCHLEAR IMPLANT

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ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT; COCHLEAR IMPLANT Back to Search Results
Model Number CI-1500-01
Device Problems Device Dislodged or Dislocated (2923); Human-Device Interface Problem (2949)
Patient Problem No Code Available (3191)
Event Date 10/28/2015
Event Type  Injury  
Event Description
The recipient is reportedly experiencing device displacement due to thinning skin.The recipient's device was repositioned.A second repositioning surgery is scheduled.
 
Manufacturer Narrative
The recipient reportedly underwent repositioning surgery.
 
Manufacturer Narrative
(b)(4).The recipient has reportedly resumed use of the device.The recipient remains implanted.This is the final report.
 
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Brand Name
HIRES 90K¿ ADVANTAGE IMPLANT
Type of Device
COCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
Manufacturer Contact
pamela campo
28515 westinghouse place
valencia, CA 91355
6613627624
MDR Report Key5160339
MDR Text Key28685206
Report Number3006556115-2015-00482
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
P960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
Type of Report Followup,Followup
Report Date 09/28/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/31/2015
Device Model NumberCI-1500-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/20/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received11/15/2015
12/14/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2013
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) Required Intervention;
Patient Age6 YR
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