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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 302

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CYBERONICS, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 01/01/2010
Event Type  Injury  
Manufacturer Narrative

 
Event Description

The patient reported on (b)(6) 2016 that her lead is protruding and is painful because she has lost a lot of weight. She stated she lost weight and device migrated and she has a knot where she thinks the wire connected to the generator. The patient needs a mri for her left breast but the generator is right above. Follow-up with the physician showed that she needs an explant asap and it's not clear if she needs it only for the mri or for the pain, protrusion and migration too. The physician states that the pain, protrusion and migration were present before her weight loss but now the device is more prominent in her neck since her 100 lb weight loss. The mass at her connector site of the lead and generator is believed to possibly be from the lead coming loss (probably from migration of the system). From the report it seems as though the lead is protruding, painful in the neck and possibly migrating causing a mass near the generator connection. Surgery has not occurred to date.

 
Event Description

Information was received from the physician on (b)(6) 2016. It was stated that the reason for the explant was due to the need for mri for breast lump, patient was a non-responder to vns therapy anyway, and patient was experiencing pain, protrusion and migration. It was stated that the patient experienced more pain after the weight loss. The issues began 6 to 7 years ago. No surgical intervention has not occurred to date.

 
Event Description

It was reported on (b)(6) 2016 that the patient had her device explanted that day. The explanted devices were disposed of.

 
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Brand NameLEAD MODEL 302
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058
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 Key5834683
Report Number1644487-2016-01711
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Followup,Followup
Report Date 07/05/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/15/2009
Device MODEL Number302-20
Device LOT Number1528
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/24/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/15/2006
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: 07/29/2016 Patient Sequence Number: 1
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