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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104

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CYBERONICS, INC. PULSE GEN MODEL 104 Back to Search Results
Model Number 104
Device Problems Connector pin failure; Device Issue
Event Date 04/12/2010
Event Type  Malfunction  
Event Description

During revision surgery to address high lead impedance (reported in mdr 1644487-2010-00238), it was noted by the surgeon that the header of the m104 implanted in the pt had become detached. The surgeon replaced the generator and obtained acceptable diagnostics results; therefore, the lead was not replaced. Good faith attempts to obtain the explanted generator for analysis have been unsuccessful to date. The device history record for the explanted generator was reviewed. No unresolved issues were found with any of the components used in the mfg of the generator that would have impacted device performance. Additionally, the hosp submitted voluntary mdr (b) (4) providing info regarding the revision surgery including the observation that the header was detached from the generator. The report also stated that the generator was believed to be the cause for the high lead impedance and since the high lead impedance resolved with generator replacement, the lead was not replaced.

 
Manufacturer Narrative

Device mfg records were reviewed. Review of mfg records confirmed no issues with the generator prior to shipment. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NamePULSE GEN MODEL 104
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1719559
Report Number1644487-2010-01122
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/22/2010,04/12/2010
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/11/2010
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2010
Device MODEL Number104
Device LOT Number200616
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/22/2010
Distributor Facility Aware Date04/12/2010
Device Age4 yr
Event Location Hospital
Date Report TO Manufacturer04/22/2010
Date Manufacturer Received04/12/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/01/2007
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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