Pages: 1 ... 8 9 [10]
 91 
 on: August 10, 2019, 01:38:30 AM 
Started by dennis100 - Last post by dennis100
Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/19/2019
Event Type  Injury   
Event Description
It was reported that the patient was experiencing discomfort with stimulation and the patient underwent a full revision for the pain. The patient was complaining of electric shocks to the brain and behind the eyeballs and thus the doctor went ahead with the full revision. The physician did not provide an assessment of the reported pain. It was stated, though not explicitly stated by the physician, that the revision was noted to be for the patient's complaints and their intractable seizures and therefore for both patient comfort and to preclude a serious injury and thus reported. Diagnostics were reported to be within normal limits. The patient's replacement surgery facility is known to discard products after surgery and is a no return site and therefore product has not been received. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8781134

 92 
 on: August 10, 2019, 01:35:40 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/16/2019
Event Type  Injury   
Event Description
It was reported that the patient was in the hospital with hoarseness, electrical pain in the back of throat going up to the patient¿s teeth, and hand spasms. The er (emergency room) physician indicated that he assumed the events were related to vns. Further information was received that the patient was seen the week prior to the hospitalization and per the neurologist the device was working fine. It was noted that impedance was ok, but that the exact value could not be recalled. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8776992

 93 
 on: August 10, 2019, 01:33:17 AM 
Started by dennis100 - Last post by dennis100
Model Number 303-20
Device Problem Detachment of Device or device Component
Event Date 09/07/2018
Event Type  Malfunction   
Event Description
It was reported that the patient experienced pain at the neck associated with the stimulation of their vns generator. The patient felt the "great pain" every 5 minutes, and it was reported that the physician assessed this pain was due to the dislocation of the patient's electrodes. It was reported that the patient was referred for a lead revision. The physician suspected lead discontinuity, likely referring to the dislocation. There was no report of high impedance to date. The physician reported that the cause of the suspected dislocation was incorrect initial implant location. The patient was reportedly not receiving effective stimulation due to the dislocation. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8784977

 94 
 on: August 10, 2019, 01:32:37 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Event Description
It was reported that the patient was having pain in their neck during stimulation, particularly when looking to the left. Additionally, the patient¿s generator had migrated. The patient¿s generator had good impedance with no error messages. X-rays were taken that did not show evidence of a lead fracture. The device was disabled. The xrays have not been received by livanova to date. Per the physician, the patient's migration was due to patient manipulation. The patient's generator migration happened at their generator site, but per the physician the generator ended up back where it was supposed to be. The generator and lead were replaced. The devices have not been received by livanova 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=8784749

 95 
 on: August 10, 2019, 01:26:12 AM 
Started by dennis100 - Last post by dennis100
Model Number 302-20
Device Problem Fracture
Event Date 07/08/2019
Event Type  Malfunction   
Event Description
Patient experienced a fall and reported feeling neck painful stimulation after the fall. It was noted that diagnostics were performed and high impedance was found. The patient was referred for surgery evaluation for possible lead revision. It was noted that settings were lowered. Clinic notes received for the patient stated that the patient tripped and fell and then began to experience sharp electric sensations in the neck that were not experienced before. It was noted that the patient¿s neck pain subsided after the output current was decreased. The device was reported to have been disabled and it was noted that the patient felt better after disablement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8837829

 96 
 on: August 10, 2019, 01:25:33 AM 
Started by dennis100 - Last post by dennis100
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.
 
Event Description
It was reported by the patient that there was what appeared to be a pocket of pus at the generator site and the electrode/neck site was getting red and swelling. Follow up revealed that there was no infection at the electrode/neck site. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. No relevant surgery is known to have 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=8823755

 97 
 on: August 10, 2019, 01:24:57 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/28/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient's vns generator seemed to have migrated. The neurologist indicated that the generator migration may have caused the vns lead wires to press on the patient's thoracic duct and obstruct flow. The patient experienced swelling of the left arm, neck, leg, and hand. The neurologist indicated that the patient's left hand was more swollen than the right and was concerned the swelling may have been related to lymphedema. The patient's neurologist ordered the patient a compression garment. Clinic notes were received that mentioned x-rays were performed of the patient's neck and chest. The x-rays have not been received by the manufacturer for review to date. The notes indicated that the x-rays showed strain relief loop and that the leads were positioned appropriately. The x-ray notes reported the generator appeared to overlie the left chest, and per the x-ray assessment made by the surgeon the generator had not migrated into the armpit where it could endanger the lymphatic area. The patient was referred for generator replacement. No known relevant surgical intervention has occurred to date. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8775657

 98 
 on: August 10, 2019, 01:24:16 AM 
Started by dennis100 - Last post by dennis100
Model Number 7304
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/14/2019
Event Type  Injury   
Event Description
It was reported that a study patient experienced a neck burn considered to be "probably related" to the vitaria implant procedure. Attempts for further information could not be made. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8754589

 99 
 on: August 10, 2019, 01:23:40 AM 
Started by dennis100 - Last post by dennis100
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

 100 
 on: August 10, 2019, 01:23:02 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient reported that they experienced pain and swelling in their neck that started about two months prior to the report. The patient described the pain as a pulling sensation and knotting in the neck. Per the patient, the neurologist mentioned that the stimulation is irritating the patient's muscles, but referred the patient to the surgeon for a consult. Further follow up with the neurologist's office confirmed that the cause of the neck pain and swelling was due to the device migrating to the right side. The patient has been referred to the surgeon for further assessment. Per the physician, the referral for surgery is for both patient comfort reasons and to preclude serious injury. It was mentioned that this is all the information that the physician's office has at this point in time. 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=8756469

Pages: 1 ... 8 9 [10]