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dennis100
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« Reply #150 on: March 29, 2019, 08:10:43 AM »

Event Type  Injury   
Event Description
It was reported that a vns patient had a weight loss. It was reported that the patient has lost around (b)(6). The device parameters were modified due to that event, without any improvement. No further details were provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5403554
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dennis100
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« Reply #151 on: April 03, 2019, 01:18:18 AM »

Model Number 302-20
Event Date 04/07/2016
Event Type  Malfunction   
Event Description
It was reported that during generator replacement for end of service the surgeon identified a lead fracture. It was reported that the generator had flipped in the pocket so many times that it resulted in a lead fracture. The patient had lost a total of 100 pounds which resulted in the generator becoming loose in the pocket and started to flip. There was no patient manipulation that resulted in the flipping generator. The physician did not perform a full revision at that time. The lead replacement surgery has not occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5627975
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dennis100
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« Reply #152 on: April 06, 2019, 02:07:14 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2019
Event Type  Injury   
Event Description
It was reported that the patient has had pain, stridor, and the feeling of nerve pulling. The patient had lost sixty pounds. The patient was referred for surgery to replace and reposition the generator. Programming history was reviewed for the patient and was only available on the date of implant. No anomalies were seen. Surgery is likely but has not occurred to date. There is no additional or relevant information received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8412313
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dennis100
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« Reply #153 on: April 07, 2019, 02:33:37 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/08/2008
Event Type  Injury   
Manufacturer Narrative
This report is a continuation of medwatch mfr. Report #1644487-2008-01557.
 
Event Description
The patient has been referred for vns system explant due to generator migration and discomfort. The patient's surgeon has confirmed that the explant surgery is for patient comfort, and not to preclude serious injury. It was reported that the generator has migrated into the patient's breast since the patient has lost 300lbs. The patient's weight loss has been attributed to lifestyle choices, with the patient reportedly walking 5 miles a day. The patient states that the generator is now causing discomfort, which the patient believes is the result of the generator migration. The patient stated that the generator has been depleted for several years; however, they have remained seizure free. No known surgical intervention has occurred to date. No other relevant information has been received to date. This report is a continuation of medwatch mfr. Report #1644487-2008-01557.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8409891
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dennis100
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« Reply #154 on: April 07, 2019, 02:34:21 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2019
Event Type  Injury   
Event Description
It was reported that the patient lost 25 pounds and spent 9 days in the hospital. The patient was reported to have trouble swallowing medicine or food. It was reported that the patient had pneumonia due to aspiration. Further information was received that the patient has multiple medical conditions that cause excess salivation, drooling, and problems swallowing therefore the physician believed that vns stimulation and patient condition contributed to the difficulty swallowing. The cause of the weight loss was stated to be unknown, but the patient had been sick which the physician believed was impacting the weight loss. The physician did not believe that the weight loss occurred due to the vns. No further intervention was reported to have occurred. The patient was reported to be gaining weight and doing better. Impedance was noted to be normal.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8413880
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dennis100
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« Reply #155 on: April 09, 2019, 12:45:58 AM »

Model Number 302-20
Event Date 01/01/2010
Event Type  Injury   
Event Description
The patient reported on (b)(6) 2016 that her lead is protruding and is painful because she has lost a lot of weight. She stated she lost weight and device migrated and she has a knot where she thinks the wire connected to the generator. The patient needs a mri for her left breast but the generator is right above. Follow-up with the physician showed that she needs an explant asap and it's not clear if she needs it only for the mri or for the pain, protrusion and migration too. The physician states that the pain, protrusion and migration were present before her weight loss but now the device is more prominent in her neck since her 100 lb weight loss. The mass at her connector site of the lead and generator is believed to possibly be from the lead coming loss (probably from migration of the system). From the report it seems as though the lead is protruding, painful in the neck and possibly migrating causing a mass near the generator connection. Surgery has not occurred to date.
 
Event Description
Information was received from the physician on (b)(6) 2016. It was stated that the reason for the explant was due to the need for mri for breast lump, patient was a non-responder to vns therapy anyway, and patient was experiencing pain, protrusion and migration. It was stated that the patient experienced more pain after the weight loss. The issues began 6 to 7 years ago. No surgical intervention has not occurred to date.
 
Event Description
It was reported on (b)(6) 2016 that the patient had her device explanted that day. The explanted devices were disposed of.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5834683
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dennis100
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« Reply #156 on: April 24, 2019, 02:04:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2017
Event Type  Injury   
Event Description
It was reported to a company representative by a surgeon¿s office that a vns patient wants to have her vns removed. Follow-up to the treating neurologist¿s office provided the patient was last seen on (b)(6) 2016 and requested that device be turned off due to perceived weight loss. The neurologist turned off the device at that time and told the patient to contact the surgeon if she wanted it removed. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Clinic notes were received for surgical referral providing the patient reports it won¿t allow her to gain weight.
 
Event Description
The patient was referred for replacement due to decreased appetite and weight loss. The neurologist did not know if the decreased appetite and weight loss was related to stimulation or presence of the device. Programming history was reviewed and no programming anomalies were seen. Surgery is likely but has not occurred to date. No additional or relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6405006
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dennis100
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« Reply #157 on: May 03, 2019, 01:49:57 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/25/2011
Event Type  Injury   
Event Description
It was reported via clinic notes that a vns patient was experiencing an increase in seizures. The patient was referred for surgery. The physician stated the generator was interrogated and confirmed the device "is functioning well". Follow-up from the patient on (b)(6) 2017 also provide that she has had issues with different seizure types and frequency since last replacement. She stated seizures now happen every 2 weeks when they were happening every 4-5 weeks, lasting up to 2. 5 minutes and her recovery can be up to a week. Follow-up from the physician provided that the most recent diagnostics were normal with no error and the device was not at end of battery life. The patient¿s husband has reported increasing seizure frequency and severity past 3-6 months. The physician provided it is unclear if the increase in seizures was related to vns and mentioned the device is likely needing replacement. There is high suspicion for non-epileptic seizures co-existing with her epilepsy. Battery status indicator was reported to be normal. The change in seizure pattern and post-ictal duration is unclear if it is related to vns. It is suspected that the patient has pnes (psychogenic non-epileptic seizures) as well. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the patient provided that she was still experiencing seizures and that she can no longer feel the magnet swipe.
 
Event Description
Follow-up from the patient provided that the generator has migrated close to her armpit due to her weight loss and is bothersome. The patient reports that she has had increased seizures within the last year and does not feel the vns is working. The patient also stated she had a really rough week as she has had a lot of seizures.
 
Event Description
It was reported by the patient that her device was turning on every 10 seconds, and staying on for about 10 seconds. The stimulation was very strong and painful and making it difficult to swallow. She reported that generator location makes it difficult to access with the magnet to disable the device. It was indicated by the surgeon that the patient's replacement surgery was due to battery depletion and her migration would be fixed at this time. Per the surgeon, the surgery was not to preclude a serious injury. No surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient underwent replacement due to battery depletion. The explanted product was returned. The patient reported that she had been having sleep apnea, buzzing in her neck during sleep since 2011. She also indicated that she had felt stronger stimulation in her neck and that she gagged with magnet swipes which had led to weight-loss in the past. The patient's treating physician indicated that this patient was a high anxiety patient. It was found that the patient had multiple complaints requiring investigations of increased seizures, pain with stimulation, dysphagia with stimulation, and perception of stimulation since 2011 that were previously considered separate events. Three reports regarding seizures of this patient were submitted since 2011. In mfr. Report #1644487-2012-00443, the patient reported that she'd had an increase in seizures in january 2012, a tightness in her neck, a decreased range of motion of her neck, and pain and clicking in her throat with stimulation. The physician said that the patient's increased seizures were not related to vns. The physician stated that he believed that the patient¿s pain and ¿tightness¿ or limited range of movement, were psychiatric in nature and not related to vns. In (b)(6) 2015, mfr. Report #1644487-2015-04964, captures a report from the patient that she had a new type of seizure while having her vns settings adjusted. This seizure was later indicated not to be related by the physician and the physician indicated that the patient's seizures had decreased in severity since having the vns. Mfr. Report #1644487-2015-05446 reported that in (b)(6) 2015 the patient had experienced an increase in seizures due to her "levels being low. " the physician indicated that the patient had an extremely variable seizure pattern and that her history is not reliable. Further relevant information to these reports will be captured in the current manufacturing report as these reports appear to be related. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental mdr 4 inadvertently reported that the generator was returned when it was actually discarded.
 
Event Description
The physician indicated that the relationship of the following symptoms---sleep apnea, buzzing in neck, stronger stimulation in her neck, and gagging with magnet swipes which had led to weight-loss in the past--- was unknown. The patient's explanted product was discarded. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434722
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dennis100
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« Reply #158 on: May 05, 2019, 12:57:50 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/14/2016
Event Type  Injury   
Event Description
A call was later received on (b)(6) 2016 from the patient providing her weight loss was unintentional and associated with vns per her physician. The vns was turned off by the physician on (b)(6) 2016, but they had not seen her since that appointment. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6426823
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dennis100
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« Reply #159 on: May 09, 2019, 07:15:01 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2016
Event Type  Injury   
Event Description
It was reported that the patient's device had migrated. The cause of the migration was unknown, and the surgery was being done due to the concern that the generator may detach from the lead wire. The surgeon reported that x-rays from 2014 and from after the migration reportedly started were compared, and the generator appeared to be in the same position. However, the surgeon had not evaluated if the patient's device was able to migrate while in the pocket. Also, the patient had lost a lot of weight prior to the migration beginning. The surgeon suspected that the patient felt like her device was migrating due to the weight loss. The type of suture used during implant surgery was not recorded in the operative notes. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6515068
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dennis100
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« Reply #160 on: June 07, 2019, 05:18:15 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary because the reported event have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient was referred a generator site revision due to pain at the generator site. The patient had severe weight loss and it was recommended that the patient would replace their generator with a smaller generator. The generator was replaced. Per the physician¿s office, the patient¿s weight loss was due to bariatric surgery a year ago and unrelated to vns. The patient¿s pain was related to the migration, as the device would twist and move in the loose skin. The replacement was for both patient comfort and to preclude serious injury. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8591645
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dennis100
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« Reply #161 on: June 08, 2019, 05:21:27 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/27/2019
Event Type  Injury   
Event Description
It was reported that the patient has had a fever, severe vomiting, and weight loss following vns replacement surgery. The patient was hospitalized, and the patient reported that the physicians believe that the patient has acute gastritis caused by damage to the vagus nerve. The device was not turned on following replacement. The patient was later released for the hospital. During the full replacement surgery, it was reported by a sales representative that there wasn¿t anything abnormal. The lead impedance was normal and the device was not programmed on. Device history records were reviewed for the generator and lead. There were no unresolved non-conformities, and the devices passed all specifications prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8637187
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dennis100
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« Reply #162 on: June 22, 2019, 03:32:11 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/08/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Information was received from the patient that vns made her seizures 10 times worse and because she already had lots of seizures, it had to be explanted. The explanted device has not been received for analysis to date. No additional or relevant information has been received to date.
 
Event Description
Additional information was provided regarding the explant in 2013. It was stated that an exact reason for the explant was not provided in the patient's notes, but there was no indication of a device issue or malfunction in the notes either. There was a note from 2013 that stated the patient had pain from the vns (not specified location) due to weight loss and that the patient wanted the device removed. This was all the information that was able to be provided. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7183233
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dennis100
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« Reply #163 on: July 04, 2019, 01:08:51 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient¿s generator is loose in the pocket and can be flipped over. The patient has been referred to a surgeon for revision. No known surgery has occurred to date. No additional or relevant information has been received to date.
 
Event Description
Operative notes were received. Notes state that new generator was secured with an 0 prolene suture, which is a non-absorbable suture. It was noted that the referral was to alleviate pain.
 
Manufacturer Narrative
The event was attributed to the patient's physiology and therefore device evaluation is not necessary because the reported event have been determined as not related to vns therapy.
 
Event Description
Information was received that the patient would not be getting surgery to adjust the vns position. It was noted that the patient had lost a lot of weight which appears to have contributed to the movement but the patient no longer desires repositioning surgery. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7704750
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dennis100
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« Reply #164 on: July 27, 2019, 12:33:43 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/29/2018
Event Type  Injury   
Event Description
It was reported that the patient was not eating, drinking and was losing weight. Device diagnostics for the vns device were within normal limits. Information was received in a fax from the physician that the loss of appetite and weight loss were present prior to the vns implant. The physician stated that the patient feels the vns device may have worsened the symptoms. The physician also felt that vns may have exacerbated the issues however did not believe it was a primary cause of the weight loss and reduced appetite. The physician stated that the loss of appetite and weight loss were attributed to a general medical condition and dysphagia. The physician stated that the vns device was turned off to see if the symptoms improve. The patient has also been referred to a gastroenterologist for further evaluation. A feeding tube was considered to be used for the patient as well. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8218860
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dennis100
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« Reply #165 on: August 10, 2019, 01:01:51 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 #166 on: September 06, 2019, 11:37:27 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
Clinic notes were received as part of the referral process for a prophylactic vns generator change. Within the clinic notes it was reported that the patient has experienced vocal cord paralysis and severe weight loss with the vns therapy system. It was noted that the patient had experienced some voice problems and saw an ent provider who told the patient that they have a paralyzed vocal cord on the left and it may be due to the vagal nerve stimulator. It was mentioned that due to the vocal cord paralysis, the patient has experienced issues choking on liquids. It was noted that since vns implant, the patient has lost a significant amount of weight and went from about (b)(6) pounds down to (b)(6) pounds all occurring during treatment for their brain tumor. At the patient's most recent appointment it was observed that the generator "catches on things in its current location. " the physician discussed the likely need to reposition the generator more medially as he is in agreement that it frequently catches on things in its current location. (generator protrusion has been reported in mfr. Report # 1644487-2019-01619) multiple attempts have been made to the surgeon and physician for additional information on this report; however, no response has been received to date. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8918266
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dennis100
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« Reply #167 on: October 12, 2019, 01:06:20 AM »

Model Number 302-20
Device Problem Fracture
Event Date 08/19/2019
Event Type  Malfunction   
Event Description
Notes indicated that the patient will need lead revision for high impedance. Notes state that the vns is not working properly due to lead malfunction and will be scheduled for a vns revision. It was also noted that the patient has lost a lot of weight and that the generator shifts inside the pocket and a lot of the time can be sore. For the pain/migration the plan is to reposition at the time of surgery. It was noted that the surgery is for patient comfort and that the device is out of position. Regarding the cause of the migration, it was noted that the non absorbable suture may have come loose and weight loss may have played a part. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9009155
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dennis100
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« Reply #168 on: October 12, 2019, 01:06:56 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/05/2019
Event Type  Injury   
Event Description
It was reported that the patient had lost weight resulting in the lead wire showing and bothering the patient. The patient was referred for device explant. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9135828
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« Reply #169 on: October 12, 2019, 01:07:38 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/08/2019
Event Type  Injury   
Event Description
Patient¿s mother reported that the generator moves when the patient lays on her side. Patient was referred for generator replacement as a result of the migration and the generator battery being at 50%. The physician noted that the referral for device replacement was for patient comfort and to preclude any sort of future issues that may arise due to the device migration. The migration was reported to be a result of the patient's weight loss. Diagnostics were reported to be ok. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9005782
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