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Author Topic: Protrude/Extrude  (Read 181577 times)
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dennis100
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« Reply #720 on: July 16, 2019, 11:13:44 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/11/2015
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported events were not related to the functionality of the device.
 
Event Description
It was reported that a patient has been experiencing nausea and pain since having the m105 generator implanted. She stated that the generator was too large for her small frame, as she weighs 105 pounds, and the generator is visible through her clothes. The patient also stated that the generator moves when she moves her arm. She was looking to receive a smaller generator as the m103 generator gave her no issues. Follow up with the surgeon's office confirmed that non-resorbable suture was used to secure the generator. It was further stated that a m103 device was placed in aug 2015 and that the surgeon's office had not heard from the patient in regards to nausea, pain, protrusion or migration. Attempts were made for follow-up with the psychiatrist's office. It was stated that the patient had spoken to the physician regarding a larger implant, but no other information was available. It could not be clarified if a model 103 device or model 105 device was implanted. It was stated that the patient was scheduled for explant surgery due to the reported events. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7921428
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dennis100
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« Reply #721 on: July 20, 2019, 10:47:25 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/07/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
 
Event Description
Initial report was that a patient's generator had "worked its way out of the pocket. " the patient was recently implanted in (b)(6) and was reported to be scheduled for a procedure. Further information was received that the patient's generator was explanted and that there was no suspected infection at the time. A culture was sent to verify. Further information was received in clinic notes. The clinic notes speak to the patient's generator extruding from the skin due to superficial placement. The family states since placement of the generator it appeared more superficial than previous devices and the physician confirms this. The patient is stated to be referred for the generator to be removed and replaced. The notes speak to the patient having an infection at the site now requiring removal and replacement. Further follow-up was performed for information related to the infection and it was confirmed that no infection was present. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8107897
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dennis100
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« Reply #722 on: July 23, 2019, 01:03:26 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/12/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient had a generator replacement surgery due to generator extrusion. Per the surgeon, the patient's generator had eroded through the incision site. The company representative noted that the patient was very frail. He noted that the surgeon had to make a new pocket for the replacement generator. The device history records were reviewed for the generator and indicated that the generator was sterilized according to specifications. Device evaluation is not necessary because the reported event has been determined as not related to vns therapy. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8136233
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dennis100
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« Reply #723 on: July 30, 2019, 10:43:06 AM »

Model Number 304-20
Device Problem High impedance
Event Date 02/08/2019
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on the patient's vns. It was believed that the ent surgeon who performed exploratory surgery to investigate a bulge in the patient's neck had nicked the vns lead. The bulge was revealed to the protrusion of a vns lead tie-down. Follow up with the medical professional revealed that the high impedance was the result of the exploratory surgery as the impedance was within normal limits prior to the surgery. It was reported that the exploratory surgery was to preclude serious injury as it was to explore a left neck nodule. However, as the date was not provided for the lead impedances prior to the surgery, it cannot be confirmed that the diagnostics pre-operatively were within normal limits. The protrusion of the vns tie-down is reported in mfg. Report #1644487-2019-00448. The patient underwent vns lead replacement surgery. During product return attempts, it was revealed that the facility, historically, does not return explanted products and discards in surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404308
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dennis100
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« Reply #724 on: August 10, 2019, 12:24:06 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/19/2019
Event Type  Injury   
Event Description
It was reported by the physician's office that the patient's generator was dropping low and that you could see it. It was noted to be gross. The device history records of the generator were reviewed. Sterilization of the generator prior to release for distribution was verified. No further relevant information has been received to date. No known intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8786676
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dennis100
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« Reply #725 on: August 10, 2019, 12:24:47 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient who reported since last implant they have lost 30 lbs over the past 6 months. The device has migrated causing pain at the generator site. The generator is poking out and there is an area in the wound that is opening where the last stitch was located. The issue was noted in february and has gotten worse to the point where the wound in draining with blood. There was no infection reported nor a fever. The generator site was stated to be painful and purple/black. The patient does not think the device is protruding. The patient was informed by neurologist to see pcp before seeing surgeon. During follow-up it was stated that the patient was scheduled for revision surgery as there was a hole in their chest. Additional information was received from the surgeon that the cause of the migration, extrusion and dehiscence wound was patient manipulation. No non-absorbable sutures were used when the generator was implanted. Intervention is planned for the migration, extrusion and dehiscence wound to preclude infectious issues. It was stated that there was no relationship between the weight loss and vns. When asked what the believed cause of the bruising was it was stated none, therefore the cause is likely not known. No settings or diagnostics is known. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8823879
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dennis100
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« Reply #726 on: August 10, 2019, 12:25:25 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/03/2019
Event Type  Injury   
Event Description
It was reported by the patient that their vns lead was protruding and that they experienced neck irritation/sensitivity. It was indicated that the patient felt discomfort when he tugged on his neck or moved their neck too far back. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8824745
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dennis100
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« Reply #727 on: August 10, 2019, 12:26:05 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/15/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, code 81: device evaluation is not necessary as the extrusion is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient underwent wound revision surgery due to the lead eroding out of the skin at the chest post generator replacement in april. The surgery consisted of irrigating the site with saline and bacitracin and moving the generator more medially to keep the patient from picking at the site. Information was received that per the physician, the cause of the patient's extrusion is due to the patient picking at the device. It was stated that the surgery was not due to patient discomfort but just due to a "tic" as the patient has a tendency to pick at things. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8827124
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dennis100
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« Reply #728 on: August 10, 2019, 12:26:46 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/28/2013
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.
 
Event Description
Patient underwent generator explant as a result of the device poking through the patient's upper left chest skin. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8832860
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dennis100
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« Reply #729 on: August 10, 2019, 12:27:24 AM »

Model Number 30X-UNK
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/02/2019
Event Type  Injury   
Event Description
It was reported by an unknown patient through his general practitioner to the surgeon that the patient's lead had been sticking out of his neck for a year. The patient did not show-up for a consult with the surgeon. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8833594
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