MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH VIBRANT SOUNDBRIDGE; MIDDLE EAR IMPLANT

Model Number VORP

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

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

Event Date 07/05/2015

Event Type  Injury  

Event Description

The pt fell on stone on the implant side.Afterwards he had no audio processor assisted hearing perception anymore.Device explantation is planned.

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it is to be returned to the mfr for eval.When available, a device failure analysis will be submitted as a f/u report.

Manufacturer Narrative

Conclusion: damage to the coil wire, demodulator electronics and lead wire of the conductive link was determined to be the root cause of device failure.The accidental fall described in the patient report appears to match the damage found.Other damages found during investigation are attributable to the removal surgery.

Event Description

The patient fell on stone on the implant side.Afterwards he no longer had any audio processor assisted hearing perception.

• Brand Name: VIBRANT SOUNDBRIDGE
• Type of Device: MIDDLE EAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 4913017
• MDR Text Key: 6052007
• Report Number: 3004230826-2015-00044
• Device Sequence Number: 1
• Product Code: MPV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VORP
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR