Patient received a shock on 10/19, device did not transmit via home monitoring on the morning of 10/20 even though he was by his monitor.Patient came into clinic on 10/20 for device interrogation, and device was unable to be interrogated through several programmers.Due to this device behavior it was decided that the generator needed to be explanted.Device was explanted on (b)(6) 2020.
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We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.
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Upon receipt, the icd was visually inspected.The inspection revealed a spot of molten titanium on the icd housing.The icd was subjected to an electrical analysis, confirming that the device could not be interrogated.Therefore, based on the observed symptoms, it is reasonable to assume that a shock delivery into an external short circuit led to a damage of the electrical module.Due to the damage of the electrical module the device could not be interrogated, and the memory content of the device was not restorable.Possible clinical complications that might lead to an external short circuit include, but are not limited to, twiddler syndrome, subclavian crush syndrome or other lead insulation damages.The manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the observed damage characteristics.Particularly the final acceptance test proved the device functions to be as specified.There was no indication of a material or manufacturing problem.
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