MAUDE Adverse Event Report: MED-EL MED-EL CONCERT OPUS 2; MED-EL CONCERT OPUS 2 COCHLEAR IMPLANT

Device Problems Device Inoperable (1663); Noise, Audible (3273)

Patient Problems Fall (1848); Failure of Implant (1924)

Event Date 04/04/2014

Event Type  Injury  

Event Description

Child was shocked.He heard a sizzling sound, a large pop and then fell over.He said he felt like he was being electrocuted and shocked.The cochlear was no longer working and he couldn't hear anything from the implant.The cochlear was removed and he was reimplanted two years later.

• Brand Name: MED-EL CONCERT OPUS 2
• Type of Device: MED-EL CONCERT OPUS 2 COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL
• MDR Report Key: 5652264
• MDR Text Key: 45260587
• Report Number: MW5062237
• Device Sequence Number: 1
• Product Code: MCM
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 YR
• Patient Weight: 53