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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Event Date 11/20/2012
Event Type  Injury  
Event Description

Further follow-up revealed that the generator was not explanted in (b)(6) 2012 as previously reported. It was reported that the generator and lead were explanted on (b)(6) 2013 due to recurring infection. It was reported that the devices were not replaced. The generator and lead were returned for analysis on (b)(4) 2013. The returned product form listed recurrent infection and cervical pain as the reason for explant. It was reported that the patient experienced dehiscence of unknown cause in (b)(6) 2012 and that at that time explant was likely, but that the explant was not performed until now. The physician indicated that the patient experienced recurrent infection at the generator site times two (once in (b)(6) 2012 and then again in (b)(6) 2012). It was reported that the device was removed at the request of infectious disease physician. The physician indicated that the generator replacement in (b)(6) 2012 is believed to have caused or contributed to the infection. Cultures showed no organisms with occasional neutrophils with growth after 5 days. The lead pa was completed on (b)(4) 2013. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The generator pa was completed on (b)(4) 2013. The pulse generator performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

 
Manufacturer Narrative

Date of explant; corrected data: this information was found to have been incorrectly reported on initial mfr. Report. Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
Event Description

On (b)(6) 2012 it was reported that the patient was recently re-implanted with a generator and there was dehiscing at the wound site. The patient had the generator removed the next day. (b)(4) attempts for further information from the physician were made but were unsuccessful. The patient's implanted generator product information was requested from the hospital but has not been received to date.

 
Event Description

Additional information was received on (b)(4) 2012 when the implanted generator product information was received from the implanting hospital.

 
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Brand NamePULSE GEN MODEL 102
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 Key2871524
Report Number1644487-2012-03322
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/20/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2014
Device MODEL Number102
Device LOT Number3330
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/02/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/30/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/15/2012
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: 12/13/2012 Patient Sequence Number: 1
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