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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problems Detachment Of Device Component; Premature End-of-Life Indicator
Event Date 09/13/2017
Event Type  Malfunction  
Event Description

It was reported that the patient¿s device was explanted due to "battery near end of service, in the red". It was stated that the lead was not replaced. The explanted generator¿s header was detaching from the generator and it was unknown by the or specialist if this happened during surgery when the surgeon was removing the lead or if it was like this prior to surgery. It was reported that the surgeon was pulling with forceps to pull the generator out and was unsure if it happened prior to or during the explantation, but it did appear that she was using some force to get the battery out. They did not conduct system diagnostics prior to surgery and only interrogated the device to get old settings. It was also alleged that the m106 battery that was explanted depleted quicker than expected. The device history record was reviewed, and it showed that the device passed all specifications prior to release. The device was also laser-routed during manufacturing. Data from the generator was reviewed, which showed that the battery voltage was dropping more quickly than expected as compared to the amount of charge that had been consumed. This was most likely related to the laser-routing process during manufacturing, which is known to leave debris on the edge of the printed circuit board, thus providing a leakage path for current from the battery. The explanted generator was received for analysis and analysis is currently underway but not yet completed and approved.

 
Event Description

Product analysis for the generator was completed and approved on 10/17/2017. Visual observations showed that the header was detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was detached from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process. The pulse generator was opened. A visual assessment on the pcba, performed showed contaminates on the trimmed edge of the pcba (tab removed). No other visual anomalies were identified. During the bench interrogation, the pulse generator interrogated at a distance of one and one-quarter inches (spacer block) between the pulse disabled and eos warnings were set. The battery was removed. The printed circuit board assembly (pcba) was subjected to a postburn electrical test and results show that the pcba failed several electrical tests: r2 verification, supply current 2 ma/normal, supply current off, supply current off sense, magnet detection normal, magnet response, and trim diagon current. Fine grit sandpaper and isopropyl alcohol were used for the removal of the observed contaminates from the trimmed edge of the pcba. Based on the postburn electrical test results, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6921975
Report Number1644487-2017-04553
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/09/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/23/2017
Device MODEL Number106
Device LOT Number4405
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/25/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/17/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/10/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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