MAUDE Adverse Event Report: MEDTRONIC XOMED INC. SOPHONO®; HEARING AID, BONE CONDUCTION

Model Number UNK SOPHIMPL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abscess (1690)

Event Type  Injury  

Manufacturer Narrative

Product evaluation: analysis results not available; device not returned for evaluation.

Event Description

This file will investigate the findings in the article ¿contralateral routing of signal hearing aid versus trancutaneous bone conduction in single-sided deafness¿, audiology nurotology, 2015; 20 (4): 251-260.¿this study was a crossover multicenter study, comparing a cros [contralateral routing of signal] hearing aid to alpha 1 for the rehabilitation of ssd [single-sided deafness] in adults.¿ a total of 24 patients were initially included in the study, 18 of which underwent both cros and alpha 1 trials.¿the cause of dissatisfaction with alpha 1 [sophono] was physical discomfort in 1 case (6%) and poor sound quality for 3 others (17%).¿ ¿no intraoperative complication was reported.The immediate postoperative course was also uneventful.Ten days after the implantation, 2 regressive hematomas (15%) were noted.One case of local abscess (8%) required explantation and subsequent reimplantation.One month after surgery, 5 patients complained of local pain, and 1 patient still had a local erythema which persisted during the observation period.¿ three months after implantation of the alpha 1, 1 patient was unsatisfied and complained of residual local pain.One year after implantation, 3 patient reported local discomfort.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SOPHONO®
• Type of Device: HEARING AID, BONE CONDUCTION
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 5920019
• MDR Text Key: 53658714
• Report Number: 1045254-2016-00282
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK SOPHIMPL
• Device Catalogue Number: UNK SOPHIMPL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention