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dennis100
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« on: January 29, 2017, 02:33:40 AM »

Model Number 250
Event Date 09/01/2009
Event Type Malfunction
Event Description
It was initially reported that the pt's magnet activations were not registering on the handheld computer and old activations were missing from the history. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1553407
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dennis100
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« Reply #1 on: January 29, 2017, 02:34:28 AM »

Model Number 250
Event Date 01/26/2011
Event Type Malfunction
Event Description
It was reported on (b)(6) 2011, that a magnet display error occurred when a doctor was visiting with a pt on (b)(6) 2011. The doctor claimed that "the date of the activations remained the same, but each time stamp would appear under the same date", that is a different index. Each index would contain the same date and time stamps, but one less time stamp than the previous index. F/u with the physician was made and the error was said to look like a pyramid shape - every entry line had one less time stamp than the previous entry. It was explained that this error was triggered by a roll-over in the counter of the patient's generator after it reaches 65536 hours, which causes the vns software to incorrectly display the magnet swipes; however a company rep stated that the patient's generator had not yet rolled over as the patient's counter was at 60698 hours on (b)(6) 2011. Good faith attempts to date for more info on the error have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2022965
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dennis100
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« Reply #2 on: January 29, 2017, 02:35:18 AM »

Model Number MODEL 250
Event Date 03/30/2011
Event Type Malfunction
Event Description
It was initially reported that the pt total magnet activation count was not increasing with magnet activations. The nurse reported that the pt swipes his magnet several times per week, however, the total number of magnet activation were the same in (b)(6) 2010 and (b)(6) 2011. The magnet was swiped in the office and the pt felt stimulation. After re-interrogating the pt, the total magnet activations had not increased. There is no suspected issue with the pt's generator. Good faith attempts to gain programming history are in process.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2086611
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dennis100
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« Reply #3 on: January 29, 2017, 02:36:19 AM »

Model Number 250
Event Date 11/20/2009
Event Type Malfunction
Manufacturer Narrative
Code analysis of programming history.

Event Description
During mfr review of vns programming history for a pt, it was noted a magnet mode diagnostics test resulted in low output current on (b)(6) 2009. Systems diagnostics tests were within normal limits. The low output current warning on the magnet mode test is a result of the user not swinging the magnet before performing the magnet mode diagnostics test. The low output current result is likely due to the generator comparing the last magnet swipe output to the newly programmed magnet mode output current which had not been delivered yet. The "magnetcount" variable was not being updated upon initial interrogation of the generator. The magnetcount was obtained from the last programming session on the handheld from the last generator. The reason the warning message was not displayed that a magnet swipe had not been detected is due to the way the handheld software obtains the magnetcount variable to determine if the message should be displayed. This will be implemented in v8. 0 software upgrade of the handheld computers. It will provide a software fix for scenarios in which performing a magnet mode diagnostic without performing a magnet swipe will not result in the warning message that a magnet swipe was not detected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2006844
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dennis100
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« Reply #4 on: January 29, 2017, 02:37:07 AM »

Model Number 250
Event Date 09/16/2010
Event Type Malfunction
Event Description
It was reported that the pt's vns was found to have its output and magnet currents set to 0ma during the first interrogation of a routine office visit. Clinic notes were received that confirmed the issue as reported. A copy of the programming history has been requested but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2006806
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dennis100
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« Reply #5 on: January 29, 2017, 02:38:06 AM »

Model Number 250
Event Date 01/10/2011
Event Type Malfunction
Manufacturer Narrative
Method: analysis of programming history performed.

Event Description
It was reported by the treating neurologist that the vns patient was seen for a routine follow up appointment, it was noted upon interrogation of the vns generator that multiple magnet activations were displayed on the same line. No patient treatment decisions were affected as a result of the magnet display error. Further review of the generator programming history that was downloaded from the physician's hand held and returned to manufacturer, revealed that the generator total operating time had rolled over. A manufacturer investigation has determined that the root cause for the magnet activations being displayed as multiple dates/times per row is due to the local array ((b)(4) being mis-declared as static variable, however, the trigger for this event has been identified to be the result of the generator's total operating time rolling over. The event will be corrected once 15 magnet activations have registered following the total operating time rollover.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1989748
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dennis100
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« Reply #6 on: January 29, 2017, 02:39:44 AM »

Model Number 250
Event Date 06/23/2010
Event Type Malfunction
Event Description
It was reported by a company rep that a pt's magnet activation display was out of order. The list of activations, normally displayed in descending chronological order, had the following order: (b)(6) 2011 again. Furthermore, the pt was interrogated at 1. 75 ma/20 hz/500 ms/21 sec/0. 8 min, but the pt's pulse width should have been 250 microsec. The rep stated she believed the pt was accidentally set to the 500 microsec value. Attempts for further info have been unsuccessful to date.

Event Description
Additional programming history was received that confirmed that the patient was programming to 500 usec.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2117978
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dennis100
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« Reply #7 on: January 29, 2017, 02:40:36 AM »

Model Number 250
Event Date 09/01/2009
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history performed.

Event Description
It was reported to manufacturer that when the nurse was reviewing the magnet activation history on the hand held display, that the magnet activations had a lot of magnet activations listed for one date in august, and that this did not appear to be correct. Further review of the generator programming history that was downloaded from the site's hand held and returned to manufacturer revealed that the generator total operating time had rolled over. Further manufacturer investigation has determined that the root cause for the magnet activations being displayed as multiple dates/times per row is due to the local array (tdatestr[255]) being mis-declared as static variable, however the trigger for this event has been identified to be the result of the generator's total operating time rolling over. The event will be corrected once 15 magnet activations have registered following the total operating time rollover.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1510188
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dennis100
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« Reply #8 on: January 29, 2017, 02:41:26 AM »

Model Number 250
Event Date 08/01/2009
Event Type Malfunction
Event Description
It was reported that a physician's handheld was displaying multiple time values on the magnet activation display. No functional deficiencies were reported. The physician was notified that the phenomenon occurs with pt's generators whose total operating time and total on time has rolled over. The physician was also notified that the event will resolve on its own once 15 magnet activations have registered following the total operating time rollover. Review of programming history confirmed that the pt's generator's operating time had rolled over causing the error in the magnet activation display as suspected. The root cause for the magnet activations being displayed as multiple dates/times per row is due to the local array (tdatestr [255]) being mis-declared as static variable, however the trigger for this event has been identified to be the result of the generator's total operating time rolling over.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1497659
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dennis100
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« Reply #9 on: January 29, 2017, 02:42:16 AM »

Model Number 250
Event Date 07/29/2009
Event Type Malfunction
Event Description
It was reported that a neurologist's handheld was showing multiple times of magnet activations. The neurologist called the manufacturer for further instructions. Further info from the manufacturer to the neurologist indicated that the pt's generator was fine and that it was related to roll-over of total time and magnet activations which should resolve once the pt has had fifteen magnet activations. The neurologist acknowledged and he stated that he would re-interrogate the pt's generator at the next visit. Moreover, the neurologist stated the pt was doing well with vns therapy and had no problems. Furthermore, good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1497017
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dennis100
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« Reply #10 on: January 29, 2017, 02:43:01 AM »

Model Number MODEL 250
Event Date 07/08/2009
Event Type Malfunction
Event Description
It was reported that multiple magnet activations were displayed during the interrogation of a pt's generator. Add'l info received revealed the pt had not used the magnet since his seizures are controlled. The neurologist swiped the magnet and multiple magnet activations were displayed again. Following, the neurologist contacted the mfr for support and he was told that after fifteen magnet swipes, the issue would resolve due to the pt's generator being at roll-over time. The neurologist programmed the pt to 0 ma in magnet mode and after swiping the magnet 15 times, the issue resolved. Good faith attempts to obtain add'l data have been unsuccessful to date. The event had no detrimental effect on product performance and was corrected once 15 magnet activations were registered following the total operating time rollover.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1493782
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dennis100
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« Reply #11 on: January 29, 2017, 02:43:48 AM »

Model Number MODEL 250
Event Date 07/14/2009
Event Type Malfunction
Event Description
Initial reporter indicated that their pt's generator total on time had rolled over. Their handheld computer containing (b) (4) programming software showed a magnet activation display error. The pt is able to get their magnet activations when this occurs. Manufacture is pending programming history from the site for review.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1493778
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dennis100
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« Reply #12 on: January 29, 2017, 02:44:39 AM »

Model Number 250
Event Date 08/13/2008
Event Type Malfunction
Event Description
Reporter indicated that when a vns pt was interrogated that the magnet activations had a lot of times on one row, and that this did not appear to be correct. Further review of the generator programming history that was downloaded from the physician's handheld computer and revealed that the generator total operating time had rolled over. Further manufacturer investigation has determined that the root cause for the magnet activations being displayed as multiple dates/times per row is due to the local array (tdatestr[255]) being mis-declared as static variable, however, the trigger for this event has been identified to be the result of the generator's total operating time rolling over. The event will be corrected once 15 magnet activations have registered following the total operating time rollover.

Manufacturer Narrative
Manufacturer reviewed programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1490483
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dennis100
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« Reply #13 on: January 30, 2017, 02:11:01 AM »

Model Number 250
Event Date 12/29/2010
Event Type Malfunction
Event Description
It was reported that the pt's vns was found to have its output and magnet current set to 0ma during the first interrogation of a routine office visit. Clinic notes were received that indicated the reported issue as well as a change in the programmed on and off times. A copy of the programming history has been requested but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2006805
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dennis100
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« Reply #14 on: January 30, 2017, 02:12:07 AM »

Model Number 250
Event Date 05/27/2008
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
Reporter indicated a display error was noted when viewing a pt's magnet activations on a (b) (4) vns computer. Usually the magnet activations are shown as one magnet activation per line, but in the case of this display error, the computer screen displayed several activation times on the same line in a decreasing order. Programming history was received from the site and did not indicate any magnet activation anomalies. The computer and flashcard were later returned for product analysis. Analysis of the returned computer did not identify any anomalies during testing using the ac adapter or the main battery with a full charge. During the flashcard analysis, it was identified that the archive databases contained 2 different sets of pt data. The most likely cause for the database anomaly can be associated with the flashcard being inserted into another (b) (4) computer. No other anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1338635
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dennis100
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« Reply #15 on: January 30, 2017, 02:15:01 AM »

Model Number MODEL 250
Event Date 12/29/2008
Event Type Malfunction
Event Description
It was reported that after the pt's device was interrogated, it was discovered that the magnet settings were changed from 0. 75ma, 750 microseconds to 0ma, 500 microseconds. Good faith attempts to obtain additional info have been unsuccessful to date. It is unknown at this time if the device contributed to the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1359653
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dennis100
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« Reply #16 on: January 30, 2017, 02:15:57 AM »

Model Number 250
Device Problem Device displays error message
Event Date 06/01/2009
Event Type Malfunction
Event Description
It was reported that a physician's handheld was displaying multiple time values on the magnet activation display. No functional deficiencies were reported. The physician was notified that the phenomenon occurs with pt's generators whose total operating time and total on time has rolled over. The physician was also notified that the event will resolve on its own once 15 magnet activations have registered following the total operating time rollover. The root cause for the magnet activations being displayed as multiple dates/times per row is due to the local array (b) (4) being mis-declared as static variable, however, the trigger for this event has been identified to be the result of the generator's total operating time rolling over.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1479460
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dennis100
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« Reply #17 on: January 30, 2017, 02:16:56 AM »

Model Number 250
Event Date 06/10/2009
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history performed.

Event Description
It was reported to manufacturer that when the nurse was reviewing the magnet activation history on the hand held display, that the magnet activations had a lot of times on one row, and that did not appear to be correct. Further review of the generator programming history that was downloaded from the sites hand held and returned to manufacturer revealed that the generator total operating time had rolled over. Further manufacturer investigation has determined that the root cause for the magnet activations being displayed as multiple dates/times per row is due to the local array (b) (4) being mis-declared as static variable, however, the trigger for this event has been identified to be the result of the generator's total operating time rolling over. The event will be corrected once 15 magnet activations have registered following the total operating time rollover.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1472790
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dennis100
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« Reply #18 on: January 30, 2017, 02:17:41 AM »

Model Number 250
Event Date 03/31/2009
Event Type Malfunction
Event Description
It was reported that a physician's handheld was showing multiple dates. The physician called the manufacturer for further instructions. The physician then performed magnet mode diagnostics and re-interrogated the patient, but the issued prevailed. Further information from the manufacturer to the physician indicated that the patient's generator was fine and that it was related to roll-over of total time and magnet activations which should resolve once the patient has had fifteen magnet activations. The physician acknowledged and the stated that he would re-interrogate the patient's generator at the next visit. Information received by a company representative revealed that the patient was seen by the physician for an eeg and the physician did not re-interrogate the device. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1425021
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dennis100
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« Reply #19 on: January 30, 2017, 02:18:41 AM »

Model Number MODEL 250
Device Problem Device operates differently than expected
Event Date 07/09/2009
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history performed.

Event Description
It was reported to manufacturer that when the physician had interrogated the vns pt's device and was reviewing the magnet activation history on the hand held display, that the magnet activations had a lot of times on one row, and that this did not appear to be correct. Furthermore, the physician noted that the generator total operating time was less that the total on time, which did not appear to be correct. Further review of the generator programming history that was downloaded from the physician's hand held and returned to manufacturer, revealed that the generator total operating time had rolled over. Further manufacturer investigation has determined that the root cause for the magnet activations being displayed as multiple dates/times per row is due to the local array (tdatestr[255]) being mis-declared as static variable, however, the trigger for the event has been identified to be the result of the generator's total operating time rolling over. The event will be corrected once 15 magnet activations have registered following the total operating time rollover.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1483315
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dennis100
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« Reply #20 on: January 30, 2017, 02:19:35 AM »

Model Number 250
Event Date 06/17/2009
Event Type Malfunction
Event Description
It was initially reported that during an appointment, the mother inquired about the pt's magnetic activations. When the nurse practitioner tried to bring up the magnetic history on the handheld computer, no info came up. The nurse then said that they tried swiping the magnet but still nothing came up on the screen under magnet history. During troubleshooting with the mfr, it was discovered that the handheld computer's date was set to 2002. The date was changed at that time to the correct year. When the nurse tried to review the pt's magnet history by searching with the pt's generator serial number, it showed two different pt's initials. The nurse was unable to find the pt's info in the handheld computer. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1483294
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dennis100
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« Reply #21 on: January 30, 2017, 02:20:21 AM »

Model Number 250
Event Date 11/21/2008
Event Type Malfunction
Event Description
It was reported that a dell handheld was displaying multiple time values on the magnet activation display. No functional deficiencies were reported. Follow-up revealed that the anomaly was no longer visible in the handheld. Further manufacturer investigation has determined that the root cause for the magnet activations being displayed as multiple dates/times per row is due to the local array (tdatestr[255]) being mis-declared as static variable, however, the trigger for this vent has been identified to be the result of the generator's total operating time rolling over. The event will be corrected once 15 magnet activations have registered following the total operating time rollover.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1431141
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dennis100
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« Reply #22 on: January 30, 2017, 02:21:10 AM »

Model Number MODEL 250
Event Date 12/30/2008
Event Type Malfunction
Event Description
Reporter indicated it appeared the magnet activations for a vns pt recorded on a vns handheld computer appeared to be greater than the actual magnet activations performed. The reporter swiped the magnet over the pt's generator and the vns computer later showed 2 activations. It is believed the magnet was passed over the generator twice during the magnet activation, which would record 2 activations. Vns programming history was requested from the reporter, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1340823
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dennis100
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« Reply #23 on: January 30, 2017, 02:21:52 AM »

Model Number MODEL 250
Event Date 01/13/2009
Event Type Malfunction
Event Description
Reporter indicated that there was an issue with the handheld computer that was resulting in the magnet activations screen showing multiple results per line, when only 1 result per line should be present. The product has been returned to the mfr, but analysis of the device is not yet completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1371443
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dennis100
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« Reply #24 on: January 30, 2017, 02:22:37 AM »

Model Number 250
Event Date 12/01/2008
Event Type Malfunction
Event Description
It was reported that a vns patient had been using his magnet more often than usual, however, when the physician checked the patient's magnet activation history in his handheld device, the information presented did not match the patient's description. The magnet activations shown on the handheld device for this particular patient's generator did not correlate with the magnet swipes the patient performed. The physician was sent a replacement handheld device and his old handheld was sent back to the manufacturer for analysis. The handheld and software have been received, however, device evaluation has not been completed at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1363945
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« Reply #25 on: January 30, 2017, 08:29:01 AM »

Model Number 250
Event Date 08/01/2008
Event Type Malfunction
Event Description
Reporter indicated that a depression pt's magnet output current was found to be programmed to 1. 0ma and he did not know how that particular parameter was programmed to that value. All attempts for further info are pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1191908
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« Reply #26 on: January 31, 2017, 01:57:45 AM »

Model Number 250
Event Date 01/01/2008
Event Type Malfunction
Event Description
It was reported that a dell handheld device was displaying multiple time values on the magnet activations display. No functional deficiencies were reported. Good faith attempts for product return and additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1132732
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« Reply #27 on: February 01, 2017, 02:35:04 AM »

Model Number 250
Event Date 01/01/2008
Event Type Malfunction
Event Description
It was reported that a (b) (4) handheld was displaying multiple time values on the magnet activation display. No functional deficiencies were reported. Good faith attempts to obtain additional information and product for further analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1134886
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« Reply #28 on: February 03, 2017, 02:20:42 AM »

Model Number MODEL 250
Event Date 10/05/2007
Event Type Malfunction
Event Description
Reporter indicated that the display of a patient's magnet activations on a hp handheld computer was atypical. The magnet activations showed multiple times where only one time should have been showed. Good faith attempts for product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=937591
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« Reply #29 on: February 10, 2017, 04:11:13 AM »

Model Number 103
Device Problem Energy output to patient tissue incorrect
Event Date 12/27/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported via clinic notes that the patient's magnet was swiped several times between (b)(6) 2016, but no activations appear afterwards although the facility staff reported that the patient had seizures since then. They reported that they weren't sure if the magnet was activated, but it was unclear whether the patient did not swipe her magnet during seizures that occurred after (b)(6) 2016 or if the patient's magnet swipes did not activate her generator after that date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6269026&pc=LYJ
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