MAUDE Adverse Event Report: MEDTRONIC XOMED INC. UNKNOWN OTOLOGY

Model Number XOM UNK VENT TUBE

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

Patient Problems Perforation (2001); No Code Available (3191)

Event Type  Injury  

Event Description

This information was reported in the international journal of pediatric otorhinolaryngology 78 (2014) 938¿943, in the article ¿lon g-term follow-up of otitis media with effusion in children: comparisons between a ventilation tube group and a non-ventilation tube group¿.The vent tube for all surgeries is identified as paparella type i (1.14 mm id) medtronic xomed inc 22 were treated once by ventilation tube insertion (vt1), and 44 were treated more than once by ventilation tube insertion (vt2).There were also, 23 subjects in a medication and observation only group (obs).This data was from a 5 year follow-up: tympanic membrane retraction 27% of vt1 and 11% of vt2 vs.1 in obs group perforation 8% of vt1 and 18% of vt2 vs.0 in obs group tympanosclerotic plaque (tsp) 14% of vt1 and 33% of vt2 vs.0 in obs group effusion 14% of vt1 and 7% of vt2 vs.1 in obs group vt in place (when it should not be) 0% of vt1 and 20% of vt2 when the hearing level was analyzed with linear regression model, obs group showed better hearing level than vt1 or vt2 groups in age-adjusted model.

Manufacturer Narrative

This device is used for therapeutic purposes.Note: - ¿tympanic membrane retraction¿ is defined as when a section of the eardrum is set back within the ear, deeper than its typical position.Atmospheric pressure and ear infections can cause this condition, and many times, after the infection is cleared or the pressure in the ear stabilizes, this condition spontaneously corrects itself.There are instances where additional medical intervention is performed to help improve this condition.- there are many causes of ruptured (perforated) eardrums, including but not limited to infections, trauma to the ear, or medical care (such as aggressive wax removal).Most tympanic membrane perforations will heal on their own, but there are instances where additional medical intervention is performed to help improve this condition.- tsp is defined as calcifications within the eardrum, usually resulting from recurrent infections or trauma.It is also a known risk of ventilation tube placement.Hearing aids can help alleviate symptoms of this condition, but there are instances where additional medical intervention is performed to help improve this condition.- ventilation tubes come in many different sizes and shapes which are chosen by the physician based on the child¿s anatomy.After being implanted, it is expected that the tubes will stay in for a period of time, and then fall out on their own as the child grows.The time that the tubes remain in the ear is highly variable from patient to patient.If the tubes fail to fall out on their own, the patient may require medical intervention to have them removed.(b)(4): product evaluation: no analysis results available; device not returned for evaluation.Method: no testing methods performed.(b)(4).

Manufacturer Narrative

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

• Brand Name: UNKNOWN OTOLOGY
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr north; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED, INC.; 6743 southpoint drive north; jacksonville FL 32216
• Manufacturer Contact: michelle alford ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328197
• MDR Report Key: 3994395
• MDR Text Key: 18926027
• Report Number: 1045254-2014-00184
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,health professional,lit
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/15/2014

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: Health Professional
• Device Model Number: XOM UNK VENT TUBE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2014
• Initial Date FDA Received: 08/08/2014
• Supplement Dates Manufacturer Received: 07/15/2014
• Supplement Dates FDA Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other