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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 01/30/2013
Event Type  Malfunction  
Event Description

Products were returned for analysis after a full revision surgery was performed in medwatch report number: 1644487-2013-00547. It was noted that the patient's lead pin was not fully inserted into the generator header. The pulse generator was explanted/returned due to ¿prophylactic replacement¿. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported ¿mechanical problem / punctured insulation¿ allegation was verified. A lead break was not confirmed. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The report indicated that during revision surgery there was an opening in the tubing with body tissue going into the lead body close to the generator can. It appears this portion was not returned, since body tissue was not observed on the returned lead portions. During the visual analysis an incision mark was observed on the body of the returned lead assembly. The incision mark penetrated one side of the outer silicone tubing. The incision mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for what appeared to be remnants of dried 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. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. The connector pin was inserted into the original generator 102-62570 to verify a dimensional issue in the connector portion of the lead wasn¿t preventing the connector pin from being fully inserted into a generator. No obstructions were noted. What appeared to be canted spring indentations were observed on the rear end of the small o-ring. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations. Incomplete insertion of the connector pin may have been a potential cause for the observed high impedance condition during the implant of this lead. Since a portion of the lead was not returned that was reported to have body tissue in it is unknown if this was also a contributing factor to their high impedance. The patient's reported high impedance related to a lead issue addressed in medwatch report number: 1644487-2013-00547.

 
Event Description

Device manufacturing records were reviewed which indicate that the device passed all specifications prior to distribution.

 
Manufacturer Narrative

Event description, corrected data: device manufacturing records were reviewed, but not reported on the previous mdr. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.

 
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Brand NamePULSE GEN MODEL 102
Type of DevicePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key3134918
Report Number1644487-2013-01622
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/29/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2011
Device MODEL Number102
Device LOT Number2612
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/06/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/22/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/23/2010
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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