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

Model Number SO263-00

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

Patient Problems Unspecified Infection (1930); Skin Erosion (2075)

Event Type  Injury  

Manufacturer Narrative

Analysis results not available; device not returned for evaluation.

Event Description

This file will investigate the information published in patient outcomes in magnet-based implantable auditory assist devices; oel mb, runge cl, friedland dr, kerschner je.Jama otolaryngol head neck surg.Epub april 24, 2014.The objective of this article was  assess hearing thresholds, use rates, and complications in children implanted with a miaad (magnet-based implantable auditory assist devices (miaads)) for conductive hearing loss.his study was a "retrospective analysis of children implanted with an miaad at an ambulatory care quaternary referral center since the food and drug administration approved the sophono device (sophono inc) for use in the united states (may 2011 through january 2013).Ten pediatric patients were implanted for conductive hearing loss (14 years; mean age at implantation, 9 years [range, 3.8-17.2 years]).Diagnoses included aural atresia (n = 7) and chronic ear disease and cholesteatoma (n = 3).""at the initial fitting, the device was held in place with #1 magnet strength in 5 ears, #2 magnet strength in 3 ears, #3 magnet strength in 4 ears, and #5magnet strength (strongest) in 2 ears.Difficulties following fitting, including swelling, irritation, infection, or significant decreased ability to use the device from pain or skin changes were included in the negative outcomes.There were no postoperative complications associated with surgical implantation of the device."outcomes included erythema (redness, increased blood flow to area), swelling and pain.One patient "experienced skin breakdown and returned to the operating room for revision after treatment with oral antibiotics and antibiotic ointment and a break from device use failed to improve the skin breakdown.Operative revision included improving the seating of the implant to ensure that it was as flush to the calvarium as possible with widening of the wells and placement of alloderm over the implant for another layer of protection against skin breakdown.This required 6months for revision surgery and complete healing to occur."after recognition of these negative outcomes, new recommendations were implemented including the following: initial fitting with the lowest magnet strength possible (#0 or #1).Graduated wearing schedule over 2 weeks.Counsel patients and/or parents to remove the device immediately if any discomfort, redness, or irritation occurs.When active, consider wearing soft-band device as opposed to higher magnet strength.Be extra conservative for patients with a history of skin issues from baha or multiple surgical procedures.since making these changes, the remaining 7 ears have been implanted with no negative outcomes to date.These patients have been followed up for a mean of 166 days, much longer than the mean time to first negative outcome of 63 days when the initial complications first arose in the other patients.as our initial data regarding the number of patients experiencing early skin irritation emerged, a change in fitting practice was initiated, as described in the results section.These changes in fitting practices, starting with lower magnet strengths, and gradual increase in device use were all designed to make use of the natural protective mechanisms of the skin, which have been well documented.The skin will naturally hypertrophy over time from results of repeated trauma.If this injury is not too severe, the skin thickness and toughness can compensate rather than lead to inflammatory pathways resulting in pain, cellulitis, and potential skin breakdown.Our information on use rates indicates good tolerance of the device in all patients at last follow-up.We anticipate, based on our recent absence of complications, that our current method of early fitting will substantially lessen the complications experienced with this device..

Manufacturer Narrative

Weight: (b)(6).Date of this report: 08/11/2016.Describe event or problem: additional information received: the patient who is documented in the reviewed literature article had her initial implant (b)(6) 2012.Following the procedure ¿she had ongoing concerns with soft tissue swelling and partial protrusion of her implant.She had swelling (b)(6) 2012 and was treated with oral antibiotics, cefdinir and bactroban ointment.¿ ¿from her (b)(6) 2012 visit: her difficulties are when she wears her device for extended periods of time, she develops an area of swelling over her superior magnet.When she takes the device off, it tends to go away.She did have a period of crusting, which was treated with antibiotics.She most recently finished a course of augmentin and ciprodex; however, she quickly returned to swelling after she began using her device again.¿ due to the issues documented, the patient was implanted with a new device on (b)(6) 2012.¿from (b)(6) 2012 visit: on examination she appears well.At her surgical site, it is nicely healed, but she does have an area of swelling.There is no indication for infection.She does not have erythema or pain with palpation.There is no evidence of purulence.¿ patient presented with ¿conductive hearing loss associated with aural atresia with post-operative swelling after her revision sophono placement.This was most likely associated with a seroma.This has resolved.¿ ¿from (b)(6) 2016 visit: no redness or swelling at the sites.Headaches even with different types of magnets.On (b)(6) 2016 was the last time patient was seen in clinic.¿ model number: so263-00, serial #: (b)(4).If implanted, give date: (b)(6) 2012.If explanted, give date: (b)(6) 2012.Is this a single-use device that was reprocessed or reused? no.Concomitant devices: sophono magnetic implant, model number: so263-00 serial #:(b)(4).This device was implanted on (b)(6) 2012.Rpt.Sent to fda? no.Date manufacturer received: 09/29/2016.The 510k: k102199.Usage of device: initial.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received: the patient who is documented in the literature article had her initial implant (b)(6) 2012.Following the procedure ¿she had ongoing concerns with soft tissue swelling and partial protrusion of her implant.She had swelling (b)(6) 2012 and was treated with oral antibiotics, cefdinir and bactroban ointment.¿ ¿from her (b)(6) 2012 visit: her difficulties are when she wears her device for extended periods of time, she develops an area of swelling over her superior magnet.When she takes the device off, it tends to go away.She did have a period of crusting, which was treated with antibiotics.She most recently finished a course of augmentin and ciprodex; however, she quickly returned to swelling after she began using her device again.¿ due to the issues documented, the patient was implanted with a new device on (b)(6) 2012.¿from (b)(6) 2012 visit: on examination she appears well.At her surgical site, it is nicely healed, but she does have an area of swelling.There is no indication for infection.She does not have erythema or pain with palpation.There is no evidence of purulence.¿ patient presented with ¿conductive hearing loss associated with aural atresia with post-operative swelling after her revision sophono placement.This was most likely associated with a seroma.This has resolved.¿ ¿from (b)(6) 2016 visit: no redness or swelling at the sites.Headaches even with different types of magnets.On (b)(6) 2016 was the last time patient was seen in clinic.¿.

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: 5922340
• MDR Text Key: 53784821
• Report Number: 1045254-2016-00283
• Device Sequence Number: 1
• Product Code: LXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SO263-00
• Device Catalogue Number: SO263-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: No
• 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 Weight: 17