Model Number 302-20 |
Device Problems
Break (1069); Crack (1135); Battery Problem (2885)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/16/2015 |
Event Type
malfunction
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Event Description
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On (b)(6) 2015 it was reported that the patient¿s lead seems to have ¿cracked/broken¿.Per the physician, an x-ray was taken which showed a disruption in one of the leads about 1 cm superior to the generator.It was also reported that the patient¿s battery is at end of life as it has been implanted almost 12 years.The patient was referred for surgery.Although surgery is likely, it has not occurred to date.It was stated that there was no report of high impedance prior to the consult.The patient underwent a full revision surgery on (b)(6) 2015.The explanted products could not be returned for product analysis as the hospital discards them.Good faith attempts for further information from the physician have been unsuccessful.
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Event Description
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On (b)(6) 2015 the physician reported that high impedance had been observed on a system diagnostics test.The high impedance was first seen on (b)(6) 2015.It was stated that there was no known direct trauma to the device that could have caused or contributed to the high impedance.
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Manufacturer Narrative
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Device failure is suspected, but did not cause or contribute to a death or serious injury.
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Event Description
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On (b)(6) 2015 it was reported that the explanted lead and generator would be returned for product analysis.They have not been received to date.
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Event Description
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On 10/13/2015 the generator and lead were received for product analysis.Product analysis was completed on the generator on 10/27/2015.Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition.A battery life estimation resulted in 0.50 years remaining before the eri flag would be set.Therefore, the electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the end-of-service condition is an expected event.The pulse generator module performed according to functional specifications.There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
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Event Description
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Product analysis was completed on the leads on (b)(4) 2015.The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product.During the visual analysis of the returned 199mm portion the end of the connector pin quadfilar coil appeared to be broken approximately 192mm from the end of the cut outer silicone tubing.Scanning electron microscopy was performed and identified the area on one of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting.The area on a second broken coil strand was identified as having extensive pitting which prevented identification of the coil fracture type with mechanical damage.The area on a third broken coil strand was identified as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type and no pitting.The area on the fourth broken coil strand was identified as having evidence of being worn to the point of fracture and no pitting.Flat spots and pitting was observed on the coil surface.During the visual analysis of the returned 7mm portion the end of the quadfilar coil appeared to be broken.Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with fine pitting.Flat spots and pitting were observed on the coil surface.It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting.Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution.The abraded opening and abraded open / cut areas found on the outer silicone tubing and the cut ends that were made during the explant process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing.For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the abraded open / cut found on one of the inner silicone tubes.With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
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Search Alerts/Recalls
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