Pages: 1 [2] 3 4 ... 10
 11 
 on: August 10, 2019, 03:28:52 AM 
Started by dennis100 - Last post by dennis100
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
The patient reported via social media that she had side effects after her vns implant a year prior. She said that she could not speak and had heart palpitations. The physician reportedly disabled her device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764619

 12 
 on: August 10, 2019, 03:28:08 AM 
Started by dennis100 - Last post by dennis100
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/14/2018
Event Type  Injury   
Event Description
It was reported that the patient felt as though his heart was skipping a beat since his replacement from a m103 to a m1000 vns generator. It was stated that the patient had a cardiac workup. It was stated that the patient may have a pacemaker. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8765124

 13 
 on: August 10, 2019, 03:27:23 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/11/2019
Event Type  Injury   
Event Description
A report was received that a patient has chest pain, increased heart rate, and coughing when the patient is around any metal - notably spoons and the patient's magnet. The patient stated that the neurologist lowered their settings to as low as they can go and the patient is still experiencing these events. Further follow up with the physician's office revealed that the patient has not yet been seen by the physician, but that the patient's nurse believes the patient might just not be able to tolerate her current settings. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764840

 14 
 on: August 10, 2019, 03:24:58 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/13/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient's neurologist that the patient had significant improvement in their exercise tolerability, ability to "urinate bladder", syncope episodes and bowel symptoms once their vns generator stimulation was disabled. It was reported that the patient noticed discrete episodes similar to syncope / pre-syncope involved with vns stimulation. 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=8774075

 15 
 on: August 10, 2019, 03:23:55 AM 
Started by dennis100 - Last post by dennis100
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/04/2019
Event Type  Injury   
Event Description
It was reported that the patient was in the er for bradycardia, syncope, and a possible heart blockage. The physician was questioning whether this was related to the vns. It was stated that the patient had been bradycardic ever since implant. A review of device history records revealed that the generator and lead passed quality control inspection prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764641

 16 
 on: August 10, 2019, 03:20:28 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/15/2019
Event Type  Injury   
Event Description
The physician's office reported that the patient was experiencing shortness of breath and pain/discomfort at the chest site. It was mentioned that after the vns device was turned off, the chest pain and shortness of breath resolved. The physician wanted the patient referred to the surgeon. Further follow up was performed with the physician; however, they refrained from providing additional information. 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=8808022

 17 
 on: August 10, 2019, 03:18:24 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/15/2019
Event Type  Injury   
Event Description
The physician's office reported that the patient was experiencing shortness of breath and pain/discomfort at the chest site. It was mentioned that after the vns device was turned off, the chest pain and shortness of breath resolved. The physician wanted the patient referred to the surgeon. Further follow up was performed with the physician; however, they refrained from providing additional information. 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=8808022

 18 
 on: August 10, 2019, 03:17:45 AM 
Started by dennis100 - Last post by dennis100
Model Number 304-20
Device Problem High impedance
Event Date 06/13/2019
Event Type  Malfunction   
Event Description
A report was received that a patient's device has high impedance. Further information was received that the patient originally had high impedance and now has impedance within normal limits. X-rays were performed and the neurologist reported that there were no anomalies seen. The patient is also experiencing pain across her chest. Diagnostics were attempted in different positions to check for a positional break however the impedance was within normal limits. Ap and lateral chest x-rays were received and reviewed and per the images received, the connector pin appears to be fully inserted inside the connector block. The placement of the generator is normal. The feed thru wires seem intact at pin site. The leads were located next to and just above the generator and the lead wires at the connector pins seem intact. The lead was observed in the patient¿s neck appeared to be routed toward the patient¿s left chest. A strain relief loop and bend were both present. The strain relief bend appears to be placed per labeling, with the lead placed parallel to the electrodes, except for the placement of the tie downs. Four tie-downs are also placed however not per labeling as the tie downs are not located parallel to the electrodes. No gross fractures or sharp angles were able to be visualized in the images provided. Based on the x-rays received, the cause of the high impedance cannot be determined. Note that a microfracture cannot be ruled out based on the images provided. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8769401

 19 
 on: August 10, 2019, 03:17:03 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/31/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was referred for generator replacement. Within the clinic notes, information was received that the patient experiences pain related to stimulation in their left neck, chest, and shoulder, as well as pain when their lead is palpated. Additionally, the notes mentioned that the patient suffers from left vocal cord paralysis. The clinic notes detail that the patient experienced shingles, not alleged due to the vns, and that the patient believes the shingles "messed up her device" since the reported pain did not occur until after the patient experienced shingles. Within the clinic notes the surgeon informed that the patient's symptoms and the device are not likely associated, but that the device did need to be assess to ensure that it was not causing other symptoms. It was reported in clinic notes that the device was previously checked, and that the impedance was within normal limits and the physician made no changes to the patient's settings. Additional information was received that the physician indicated that the patient's referral for replacement was due to pain. The neurologist's office indicated that the device removal due to pain is for patient comfort reasons. However, no additional information was received in regards to the vocal cord paralysis, and its relationship to the surgery referral and pain. 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=8754630

 20 
 on: August 10, 2019, 03:16:12 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/11/2019
Event Type  Injury   
Event Description
A report was received that a patient has chest pain, increased heart rate, and coughing when the patient is around any metal - notably spoons and the patient's magnet. The patient stated that the neurologist lowered their settings to as low as they can go and the patient is still experiencing these events. Further follow up with the physician's office revealed that the patient has not yet been seen by the physician, but that the patient's nurse believes the patient might just not be able to tolerate her current settings. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764840

Pages: 1 [2] 3 4 ... 10