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Author Topic: Battery  (Read 143985 times)
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dennis100
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« Reply #1260 on: August 09, 2019, 11:08:44 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 05/22/2019
Event Type  Malfunction   
Event Description
Patient underwent generator replacement surgery due to battery depletion. It was further reported that the generator was unable to be interrogated prior to the generator replacement due to battery depletion. The device history record of the generator was reviewed, and it was confirmed that the device was laser-routed during the manufacturing process. Internal investigation showed that the observed premature battery life indicators were predominately caused by conductive debris from the laser-routing process resulting in leakage paths. The explanted generator was received and product analysis was completed. The product analysis lab confirmed that the generator was at end of service condition. A visual assessment on the pcba showed contaminates on the trimmed edge of the pcba. The battery was removed. Remaining residual material on the pcba edge after the ¿test tab¿ removal manufacturing process resulted in increased current consumption (out of speciation) for both standby and pulsing modes of operation and may contribute to the reported failure to program event due to eos (end of service). There were no other performance of any other type of adverse events found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8833391
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dennis100
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« Reply #1261 on: August 09, 2019, 11:09:17 PM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 06/27/2019
Event Type  Malfunction   
Event Description
It was reported by the physician that the patient's device had unexpected short longevity. It was stated that the magnet is rarely used. The device history record's of the generator was reviewed. The generator passed final quality and functional specifications prior to release. 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=8811413
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dennis100
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« Reply #1262 on: August 09, 2019, 11:09:50 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 07/01/2019
Event Type  Malfunction   
Event Description
It was reported that the patient's vns generator was already displaying an amber battery status (ifi) after a year of implantation. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The trim test tab was found to have occurred well after the discontinuation of the laser-routing manufacturing process. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8833390
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dennis100
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« Reply #1263 on: August 09, 2019, 11:10:27 PM »

Model Number 106
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 07/13/2015
Event Type  Malfunction   
Event Description
Product analysis was completed on a generator returned from a prophylactic battery replacement surgery, and found evidence of premature battery depletion. Upon opening the generator can, visual analysis identified contaminates on the trimmed edge of the pcba. The contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths that contributed to the supply current conditions, and the battery depleting prematurely. Product analysis confirmed that the battery status was ifi=yes condition due to the contaminates on the trimmed edge of the pcba. No further anomalies were identified. The manufacturer's device history records were reviewed. The generator passed final quality and functional specifications prior to release. Based on the date of the trim tab test the generator was subjected to the laser-routing. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8429563
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