MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05 report with the FDA on 2011-01-12 for MENIETT PULSE GENERATOR 1010020601 manufactured by Medtronic Xomed Inc..
[1779330]
The customer stated she "had seven years of perfect treatment from the meniett". During a doctor visit the patient was informed of a rupture in the round window of the middle ear.
Patient Sequence No: 1, Text Type: D, B5
[8928102]
Several attempts were made to contact the physician regarding the product and patient information. Any missing or incomplete data from form 3500a is the result of information not being released by the reporter despite multiple attempts to obtain the information. The attempts to acquire the information are documented in the complaint file. This product is used for treatment, and not for diagnoses. A review of the document history report for this lot did not indicate any abnormalities in its production. The relationship to the patient's injury and the meniett pulse generator is not known, but the patient's doctor stated, "he can not say that the meniett is not the root cause. " if new information becomes available a supplemental report will be filed. Since the meniett cannot be ruled out as having caused or contributed to this event we are submitting this mdr. However, it is unlikely the meniett caused the round window perforation as no part of the device enters the middle ear. A tympanostomy tube is placed in the tympanic membrane and a cuff / plug is placed in the ear canal. The meniett then proceeds to produce small pressure "puffs" to massage the oval window. The meniett does not generate enough pressure to rupture the membrane between the middle and inner ear. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[8952001]
Mdr 1045254-2011-0002 was filed on (b)(4), 2011, and the following is supplemental information to that report. The device in question was received on (b)(4), 2011. It was tested by connecting it to an oscilloscope, and the wave patterns of the air pulses were measured. Each wave cycle was within the parameters of the device specifications. The device treatment log chart was downloaded, and no abnormalities related to this device's performance were detected during the patient's use of the product.
Patient Sequence No: 1, Text Type: N, H10
[9849718]
The following new information was reported after a recent physical exam. A comprehensive physical exam was performed and was reported by an md specialist in ent diseases, (b)(4). In this report are historical facts related to the alleged injury that were not previously reported to the manufacturer. The results are as follows: i have previously considered the matter. I noted the notes from the senior physician's statement from (b)(6) 2011. In addition, a audiogram, which also was present at my last assessment. The patient points out that she has pain and troubles; dizziness after the injury. Vertigo attacks prevented her from driving. Tinnitus and hustle made her stressed and exhausted in 2010. Last vertigo attack occurred in (b)(6) 2010. After surgery she was troubled both by the hearing impair and impair of sensation in the area around the ear. Her balance was improved gradually. I find that in the record (medical journal) 20110314, it was noted "she is very happy. No dizziness at all. " the accompanying audiogram shows deterioration between 2007 - 2009 and 2010 on the left ear. The right ear shows good and stable hearing during this period. Audiogram from before the injury, (b)(6) 2010 unfortunately lacks measurement of speech intelligibility; it is presented in audiogram from(b)(6) 2011 and is 2% which is reasonable with respect to the 'average tone value'. The average tone value before the injury ((b)(6)) and after the surgery ((b)(6)) is similar, but there is a slight difference in the sense that hearing the treble is slightly better before than after the injury and surgery. All the while, the hearing is on the right side normal and the left ear shows, before the damage, an ongoing hearing deterioration in the years 2007 - 2010. The deterioration that occurs after injury, is from an already low auditory level of the left ear. The chief statement it is stated that already 090- 928 was the patient's hearing loss in the left ear is considered grave, however, has thereafter hearing deteriorated further the average tone value on (b)(6) 2010, i. E. Before damage is equal to average tone value after surgery. The sensory loss indicated is an effect of the surgery, it happens that minor nerve branches are cut off, often this is healed during the first year after surgery (an improvement is already seen).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2011-00002 |
| MDR Report Key | 1959304 |
| Report Source | 01,04,05 |
| Date Received | 2011-01-12 |
| Date of Report | 2011-01-12 |
| Date of Event | 2010-10-30 |
| Date Mfgr Received | 2010-12-16 |
| Device Manufacturer Date | 2010-06-29 |
| Date Added to Maude | 2011-01-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MIKE MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE N. |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| Manufacturer G1 | MEDTRONIC XOMED INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE N. |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MENIETT PULSE GENERATOR |
| Product Code | ETY |
| Date Received | 2011-01-12 |
| Returned To Mfg | 2011-02-15 |
| Model Number | 1010020601 |
| Catalog Number | 1010020601 |
| Lot Number | 68316100 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR.N. JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-01-12 |