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dennis100
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« on: January 28, 2017, 11:43:18 AM »

Model Number MODEL 250
Event Date 07/16/2010
Event Type Malfunction
Event Description
Neurology reported that their (b)(4) handheld computer was cracked and not functioning properly. The site did not know how the screen cracked as they did not remember dropping it or any event that would have caused it to crack. It was reported that their handheld works intermittently and it freezes randomly while performing different operations. The product is at the manufacturer pending completion of product analysis.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1785187
« Last Edit: February 16, 2017, 01:02:40 AM by dennis100 » Logged
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« Reply #1 on: January 28, 2017, 11:44:03 AM »

Model Number HP JORNADA
Event Date 08/01/2010
Event Type Malfunction
Event Description
It was initially reported by the physician that they were having problems with their handheld. The handheld had a crack at the top of it, inhibiting the handheld to close the cover. The cover for the flashcard was also missing. No other information was given. New handheld was shipped to the site and the old handheld was returned to manufacturer for analysis. Analysis is currently in progress for the returned handheld.

Manufacturer Narrative
Conclusions: device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1854020
« Last Edit: February 16, 2017, 01:02:55 AM by dennis100 » Logged
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« Reply #2 on: January 28, 2017, 11:44:41 AM »

Model Number 250
Event Date 08/01/2010
Event Type Malfunction
Event Description
It was reported to manufacturer by the physician that the (b)(4) x50 hand held screen was cracked. The information received from the site revealed that it was unknown how the screen became cracked, and that no one at the office was able to explain what occurred. The display screen will light up, however, the screen does not respond to the touch. The hand held was returned to manufacturer where analysis is underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1834524
« Last Edit: February 16, 2017, 01:03:08 AM by dennis100 » Logged
dennis100
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« Reply #3 on: January 28, 2017, 11:45:25 AM »

Model Number 250
Event Date 10/07/2010
Event Type Malfunction
Event Description
It was reported to manufacturer that the physician was experiencing difficulties with her hand held device and that the hand held screen was not registering the screen taps. Troubleshooting was performed with the physician over the phone, however, the issue did not resolve. The hand held and software flashcard were returned to manufacturer for analysis. An analysis of the returned handheld verified the reported allegation that the screen was not registering the stylus taps. During the visual analysis of the hand held, it was observed that the screen had a hairline crack on the bottom left-hand side of the display. The cause for the reported complaint was associated with a cracked screen. There was no report of user mishandling of the device.

Manufacturer Narrative
Conclusions - device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1893149
« Last Edit: February 16, 2017, 01:03:22 AM by dennis100 » Logged
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« Reply #4 on: January 28, 2017, 11:46:14 AM »

Model Number 250
Device Problems Crack; Device inoperable
Event Date 01/01/2009
Event Type Malfunction
Event Description
It was reported that a physician's office was having issues with their programming system. They indicated that the screen was cracked and the device was inoperable. The site was sent a new handheld device and flashcard and the old one was returned to the mfr for analysis however device eval has not been completed at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577001
« Last Edit: February 16, 2017, 01:03:37 AM by dennis100 » Logged
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« Reply #5 on: January 30, 2017, 01:36:41 AM »

Model Number 250
Event Date 11/01/2008
Event Type Malfunction
Event Description
It was reported that the site was having problems with their handheld device. They could not get pass an error screen. On pressing harder, the screen cracked. Troubleshooting steps were performed, but it did not resolve the issue. New handheld was shipped to the site. Good faith attempts to have the old handheld shipped back to manufacturer have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1354558
« Last Edit: February 16, 2017, 01:03:52 AM by dennis100 » Logged
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« Reply #6 on: January 30, 2017, 08:19:22 AM »

Model Number MODEL 250
Event Date 10/30/2008
Event Type Malfunction
Event Description
Initial reporter indicated that their (b) (4) handheld would only hold a charge for 30 minutes before needing to be charged again. The serial adapter head was also reported to be cracked where you see the wires inside. The handheld is at the mfr pending completion of product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1249828
« Last Edit: February 16, 2017, 01:04:06 AM by dennis100 » Logged
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« Reply #7 on: February 01, 2017, 02:36:47 AM »

Model Number 250
Event Date 06/16/2008
Event Type Malfunction
Event Description
It was reported that a dell handheld computer's screen was cracked and would not power on. It is unknown how the screen became cracked. Good faith attempts to obtain the product for analysis have been unsuccessful to date.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1078840
« Last Edit: February 16, 2017, 01:04:20 AM by dennis100 » Logged
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« Reply #8 on: February 01, 2017, 07:47:18 AM »

Model Number 250
Event Date 03/10/2008
Event Type Malfunction
Event Description
Reporter indicated a dell vns handheld computer had a cracked serial cable and was difficult to operate. The dell handheld computer has been returned without the flashcard and is currently in product analysis.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1025498
« Last Edit: February 16, 2017, 01:04:34 AM by dennis100 » Logged
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« Reply #9 on: February 03, 2017, 02:11:14 AM »

Model Number 201
Event Date 10/24/2007
Event Type Malfunction
Event Description
Reporter indicated that the site's programming wand was not functioning properly and that communication could not be established with a test generator. It was also reported that the wand's wires were loose and that part of the wand was cracked. Product analysis was completed on the returned programming wand. No visual anomalies were identified and the reports of loose wires and cracks were not confirmed. It was found that the serial data cable had an intermittent conductor, which was the cause of the communication errors. After the serial data cable was replaced, the wand was tested and met all specs.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=950284
« Last Edit: February 16, 2017, 01:04:48 AM by dennis100 » Logged
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« Reply #10 on: February 04, 2017, 03:22:31 AM »

Model Number MODEL 250
Event Date 07/01/2006
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that his vns therapy handheld power adapter had a crack in it and it was not properly charging his handheld. Power adapter will not be available to manufacturer for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=901412
« Last Edit: February 16, 2017, 01:05:03 AM by dennis100 » Logged
dennis100
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« Reply #11 on: February 14, 2017, 02:38:00 AM »

Model Number MODEL 250
Event Date 02/20/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
The reported handheld was returned to the manufacturer and underwent analysis. Analysis of the returned handheld indicated the cracked screen was confirmed during analysis and was most likely associated with mishandling of the device. Once the screen was replaced with a known good screen, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. Analysis of the returned flashcard indicated the flashcard and software performed according to functional specifications.

Event Description
It was reported by a company representative that a new handheld was broken. The cause of the event was not mentioned in the initial communication. Further information was received by the area representative indicating the handheld was working well and the main user did not indicate if the handheld was mishandled. A replacement handheld was sent to the area representative and the reported handheld will be returned for analysis. (b)(4) attempts to obtain the reported handheld returned have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2498944
« Last Edit: February 16, 2017, 01:05:16 AM by dennis100 » Logged
dennis100
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« Reply #12 on: February 16, 2017, 01:06:05 AM »

Model Number 250
Event Date 02/06/2012
Event Type Malfunction
Event Description
A vns programming site called and reported that they noticed that their (b)(6) handheld computer was stuck on the align screen. The caller says they tried to follow the procedures to align the screen, but said that the little cross moves around the screen, but keeps going through this procedure. The caller performed a hard reset, and cleared all the data in the memory. The caller confirmed that the handheld rebooted, and went back to the screen alignment procedure. The cross continued to move around the screen when pressed, but would not proceed past this step. The caller continued for approximately 3 mins, but still said it was on this screen alignment procedure. The handheld was returned for analysis. During the analysis, it was identified that the display was cracked and unresponsive on the right-hand side. The cause for the cracked screen is unknown, but is typically associated with mishandling of the device. Once the screen was replaced with a known good screen, no further anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge.

Event Description
Additional information was received from the site that the handheld was not dropped, nor was a crack seen prior to shipping it back. It is possible this event occurred in transit.

Manufacturer Narrative
Device malfunction caused event, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2474355
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« Reply #13 on: February 24, 2017, 01:08:12 AM »

Model Number 220-3
Event Date 11/18/2008
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a vns magnet was cracked and no longer performing as intended. The magnet was replaced. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1336237
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« Reply #14 on: February 24, 2017, 01:08:56 AM »

Model Number 300-20
Event Date 11/14/2008
Event Type Malfunction
Event Description
It was reported that during generator revision surgery due to normal battery depletion, the leads were found to have "cracked" screws. Full revision surgery of both the generator and leads was subsequently performed. Follow up with the hospital revealed that the explanted lead has already been discarded and is not available for return to the manufacturer. Good faith attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1277051
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dennis100
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« Reply #15 on: February 26, 2017, 01:05:17 AM »

Model Number 100
Event Date 01/01/2006
Event Type Malfunction
Event Description
The vns patient's generator was explanted due to end of service. The generator was returned to the manufacturer for product analysis. Product analysis on the returned generator revealed a cracked capacitor in the sensing circuitry. The exact reason for this condition is unknown. It is unknown if this condition existed during the implant life. It is believed that the most likely root cause for the end of service was the programmed settings during the implant life, since no high current consumption was observed in the caged module.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1361303
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dennis100
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« Reply #16 on: March 04, 2017, 01:05:47 AM »

Model Number MODEL 250
Event Date 12/11/2013
Event Type Malfunction
Event Description
A company representative reported that his handheld will not hold a charge. It was reported that the handheld was charged and then when taken off of the charger it dies shortly after. Troubleshooting was performed by the company representative by adjusting the battery, battery latch and battery cover, but the problem still persisted. A new programming computer was provided to the company employee. The handheld is expected to be returned for analysis, but has not been received to date.

Manufacturer Narrative

Event Description
The handheld and flashcard were returned for analysis. The handheld analysis was completed on 04/23/2014. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that some of the sync cable connector leads were damaged and that some of the solder connections between the sync cable connector leads and the handheld pcb were cracked. Because of the damage, the handheld was unable to receive power from the ac adapter. The cause for the damage to the connector and solder connections is most likely associated with mishandling of the device as it appears the connector detents are not being compressed when removing or manipulating the serial data cable, thus placing an extensive amount of force on the pcb and attached cable receptacle. No other anomalies were identified. Analysis of the flashcard was completed on 04/23/2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3556014
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dennis100
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« Reply #17 on: March 04, 2017, 06:04:46 AM »

Model Number MODEL 250
Event Date 12/02/2014
Event Type Malfunction
Event Description
A programming tablet was returned to the manufacturer due to the user dropping the device and cracking the display screen. Analysis of the tablet was completed. During the analysis, it was identified that the tablet was unable to communicate with a known good generator. The cause for the anomaly is associated with two broken wire connections in the serial cable db9 hood assembly. Once the wires were soldered on to the printed circuit board, no further anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.

Manufacturer Narrative
Device failure likely caused event, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4470800
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« Reply #18 on: March 04, 2017, 09:53:18 AM »

Model Number MODEL 250
Event Date 12/03/2014
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

Manufacturer Narrative

Event Description
It was reported that the nurse practitioner's handheld will not hold a charge. A new programming tablet was provided to the nurse practitioner. The handheld was received for analysis. Analysis is underway, but has not been completed to date.

Event Description
Analysis of the returned handheld device and software flashcard was completed. No anomalies associated with the handheld main battery were identified during the analysis. The following anomalies were identified: 1) the battery latch was unlocked, preventing the handheld from turning on; 2) the display image was distorted and the inner display glass was cracked ¿ cause associated with mechanical stress; 3) the touchscreen was unresponsive ¿ cause associated with high impedance in the touchscreen circuitry, 4) the serial cable had an intermittent open connection causing the handheld to lose power intermittently while on ac power ¿ cause associated with mechanical stress. Following replacement with a known good screen, full product functionality was restored. No anomalies associated with flashcard software were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4393758
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« Reply #19 on: March 05, 2017, 04:33:19 AM »

Model Number 220-3
Event Date 06/17/2009
Event Type Malfunction
Event Description
Reporter indicated that the pt's magnet was no longer helping to abort seizures as it had before. Info was later received that the magnet was no longer initiating stimulation periods, because the magnet was cracked. The magnet was discarded and thus will not be returned for analysis.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1479465
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« Reply #20 on: March 09, 2017, 01:39:20 AM »

Model Number 220-3 OR 4
Event Date 01/01/2009
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated that a vns magnet casing was cracked, and that due to the crack the magnet would not activate the magnet mode setting on her implanted vns generator. The magnet was discarded. Follow up with the reporter's attending physician revealed vns magnet mode diagnostics had not been performed prior to the magnet being discarded, so it cannot be determined if the magnet was functional with the cracked casing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1518368
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« Reply #21 on: April 20, 2017, 12:32:33 AM »

Model Number 220-3
Event Date 03/11/2008
Event Type Malfunction
Event Description
Reporter indicated a vns magnet was not eliciting a magnet mode stimulation during a magnet mode test due to the magnet being cracked. All attempts for further info and magnet return for analysis have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1022735
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« Reply #22 on: April 21, 2017, 02:41:39 AM »

Lot Number 56966
Event Date 01/01/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated, that her daughter's watch-style vns therapy magnet cracked and no longer functioned, as it was supposed to. Good faith attempts for further information are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=968182
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« Reply #23 on: May 01, 2017, 12:07:10 AM »

Model Number MODEL 250
Event Date 07/11/2014
Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative
Evaluation codes: no device failure occurred that would contribute to the computer powering down during use. User interface caused the crack in the screen; however, the crack did not inhibit use of the computer.

Event Description
Analysis of returned tablet device was completed. A visual inspection of the tablet verified that the display was cracked. No anomalies associated with the software or battery was identified during the analysis.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

Event Description
It was reported that during surgery, the tablet kept shorting out and would power down while attempting device interrogation. A second programming tablet was used to successfully interrogate that patient's device. It was reported that the tablet had been accidentally dropped some time ago which caused a small crack in the screen, but this was not believed to cause the sudden power down. The programming tablet was received for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3995031
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« Reply #24 on: May 11, 2017, 12:04:23 AM »

Model Number 220-3 OR 4
Event Date 01/11/2008
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

Event Description
The reporter indicated that both magnets "were cracked and not working. " in addition, the reporter did not know whether the patient experienced a magnet mode stimulation at this time. Good faith attempts were made to obtain additional information and pending response.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=992182
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« Reply #25 on: May 12, 2017, 12:20:54 AM »

Model Number 300-20
Event Date 09/30/2008
Event Type Malfunction
Manufacturer Narrative
Conclusions: device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
The rptr indicated that they received a high impedance warning during revision surgery. Troubleshooting steps were performed and it was revealed that the pt's lead was the source of the problem. While explanting the lead, the rptr noted that there was a "crack all the way through the silicone on the negative lead close to the pin. " when asked if the crack could have been the result of the revision surgery, the rptr indicated that he did not think he had nicked or cut the lead during the revision process. The product was returned and is currently awaiting analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1216049
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« Reply #26 on: May 13, 2017, 02:21:03 AM »

Model Number 220-3
Event Date 09/03/2008
Event Type Malfunction
Event Description
It was reported that the pt's magnet was cracked. Good faith attempts to obtain product return for analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1191915
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« Reply #27 on: May 13, 2017, 02:21:37 AM »

Model Number 302-20
Event Date 09/18/2008
Event Type Malfunction
Manufacturer Narrative
Conclusions: device failure is suspected, but did not cause or contribute to death or serious injury.

Event Description
It was reported to manufacturer that during surgery for a generator replacement due to end of service, the surgeon visualized a lead break in the lead. Both the lead and generator were subsequently replaced. Further follow up with the surgeon revealed that only the outer tubing was broken on the lead on the portion of the lead near the generator. The surgeon further explained that the pocket that formed around the generator was very tight, and that, it maybe possible that due to arm movement for years, the insulation could have cracked immediately beyond the rigid end of the lead attached to the generator. Attempts to obtain additional information from the treating physician have been made, but have been unsuccessful to date. Additionally, attempts to obtain the explanted lead and generator for analysis have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1203124
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« Reply #28 on: May 14, 2017, 12:02:56 AM »

Lot Number 388034
Event Date 08/14/2008
Event Type Malfunction
Event Description
It was reported that a vns patient's wrist magnet was cracked. It is unknown how to the magnet became cracked. Good faith attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1172207
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« Reply #29 on: May 15, 2017, 12:11:47 AM »

Lot Number 290591
Event Date 01/01/2008
Event Type Malfunction
Event Description
It was reported that both of the patient's magnets were cracked. Patient received new magnets from her physician. It is unknown whether the patient's magnets were still performing as intended despite being cracked and broken in half.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1123856
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