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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102R Back to Search Results
Model Number 102R
Event Date 03/30/2012
Event Type  Malfunction  
Event Description

Analysis was completed , the elective-replacement-indicator (eri) was set. A window was cut into the pulse generator case to access the feed-thru output connections on the substrate. Bench test connectors were attached to the negative and positive feed-thru wires, at the substrate, to perform a final electrical test. The generator passed all final electrical testing evaluations with the exception of a single test parameter related to the partially depleted condition. The battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. The reported detachment of the header at explant was confirmed. The location of the white deposits observed on the pulse generator case suggests that header delamination/separation had occurred. The observed header anomalies found in the visual analysis may have been the contributing factor to their high impedance. The failure mechanism could not be determined; however poor adhesion and tool marks in the header area were observed on the returned product.

 
Manufacturer Narrative

Operator of device corrected data: updated to patient.

 
Manufacturer Narrative

Device malfunction occurred but did not cause or contribute to a death or serious injury.

 
Manufacturer Narrative

Type of report corrected data; omitted on initial report, 30 day report. Type of report corrected data follow-up # 3 on last emdr should have been a #2. (b)(4) , version no: 2 corrected data: the last emdr was sent version 3 when it should have been version 2. Therefore this emdr being sent version 2.

 
Event Description

Initially a battery life calculation was requested on a vns patient's generator. The patient's settings were 2. 5/30/250/30/3. Their system diagnostic testing was dcdc 3, eri no. The battery life calculation was negative. The patient went to surgery for a prophylactic generator replacement. In preop a system diagnostic test was performed that resulted in the following: high lead impedance with an ok output status, dcdc=6 and eri=yes. The patient was programmed at 2. 75ma. It was noted in the or that the patient's generator had a detached header. There was no specific trauma that was reported preceding the event. The header detachment did not occur during the explant. The explanted generator has been returned for analysis. Analysis is pending completion.

 
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Brand NamePULSE GEN MODEL 102R
Type of DevicePULSE GEN MODEL 102R
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
nydia grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2546638
Report Number1644487-2012-01054
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 03/30/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/24/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2005
Device MODEL Number102R
Device LOT Number009157
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/09/2012
Is The Reporter A Health Professional? Yes
Distributor Facility Aware Date06/07/2012
Event Location Other
Date Manufacturer Received06/07/2012
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/16/2003
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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