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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R GENERATOR Back to Search Results
Model Number 102R
Event Date 05/02/2013
Event Type  Death  
Event Description

It was reported that the patient passed away approximately 3-4 months ago. The cause of death is not know at this time. It was reported that the patient had a pacemaker and known cardiac issues which was previously reported in mfr. Report # 1644487-2013-00834. Attempts to obtain additional information will be made, but no information has been obtained to date.

 
Event Description

Additional information was received stating that the vns patient passed away on (b)(6) 2013. The patient was found dead on his bed in a supine position. The patient device¿s was disabled at the time of death and was not explanted. It was reported that the patient¿s death was not related to vns. An internal review of the available information determined that the patient¿s death was possible sudep.

 
Event Description

Additional information was received stating that the vns patient¿s device was at end of service on (b)(4) 2010.

 
Event Description

Additional information was received stating that the vns patient was born on (b)(6) 1946, not (b)(6) 1949 as initially reported. The patient¿s death certificate was obtained. The death certificate listed the immediate cause of death as cardiopulmonary arrest with probable acute coronary syndrome and probable coronary artery disease as sequential conditions that contributed to the death. The patient had other significant health conditions may have contributed to the patient¿s condition. Nurse¿s notes regarding the patient¿s death were received. The notes indicate that the patient was being closely monitored due to treatment with continuous positive airway pressure (cpap). It was noted that the patient¿s cpap mask had be adjusted frequently. No issues were noted with the patient when he was evaluated at 11:00 pm on (b)(6) 2013. At 11:45 pm, the notes indicate that nurse required assistance adjusting the patient¿s cpap mask because the patient kept removing it. At midnight, nurse reported that the patient was pale, warm to touch, breathless, non-responsive, and pulseless. Cpr was immediately initiated and the paramedics that arrived approximately ten minutes later continued cpr until the patient was pronounced dead at 12:33 am on (b)(6) 2013. Follow-up with the nurse revealed that the patient was not having a seizure at the time of death the patient¿s seizure record indicated that the patient experienced several seizures from (b)(6) 2013 which consisted of stiffening, jerking, some forward head drops, flinging of the arms. The patient¿s postictal periods were uneventful with good recovery. With the available information, an internal classification determined that the death was unlikely sudep. The patient¿s body was donated to science and the patient¿s devices were explanted. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

 
Event Description

Analysis of the returned generator and lead was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The device was confirmed to be at end of service as result of normal battery depletion. The depletion was an expected event as determined by the blc and battery voltage measurement. The module performed according to functional specifications. There is no evidence to suggest an anomaly with the returned portions of the lead. During the visual analysis, the (+) white and (-) green electrodes appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the ribbons from coming in contact with the vagus nerve. With the exception of the tissue-covered (+) white and (-) green electrodes, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins 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 discontinuities were identified. Note that since a large portion of the lead assembly (body) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

 
Manufacturer Narrative

 
Manufacturer Narrative

Additional information indicates that the patient¿s dob was (b)(6) 1946.

 
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Brand NamePULSE GEN MODEL 102R
Type of DeviceGENERATOR
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 Key3506710
Report Number1644487-2013-03715
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/11/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2007
Device MODEL Number102R
Device LOT Number014865
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/09/2014
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received09/25/2014
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/14/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/09/2013 Patient Sequence Number: 1
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