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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. BIPOL LEAD MODEL 300

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CYBERONICS, INC. BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Event Date 09/01/2011
Event Type  Injury  
Event Description

It was reported by the patient's mother that the patient had recently been diagnosed with gastroparesis by a pediatric gastroenterologist. The patient's feeding tube had begun leaking around (b)(6) 2011 and she did not understand why until she saw the physician. It was not indicated what the physician believed caused the gastroparesis. The patient previously had his vns generator removed on (b)(6) 2008, as the patient had been seizure-free since 2007 and did not require vns or anti-epileptic medication. The mother reportedly did some online research and came to the conclusion on her own that the patient's previous vns surgeries caused damage to the vagus nerve resulting in gastroparesis. A vns surgeon saw the patient for evaluation but declined to provide any information. Attempts for follow-up with the gastroenterologist have been unsuccessful to date.

 
Event Description

The patient previously had his generator explanted on (b)(6) 2007, prior to the time that the patient has experienced gastroparesis.

 
Event Description

Additional information was received from the patient's mother indicating that the patient has been experiencing gastroparesis since about (b)(6) 2011, has lost 30 pounds, and cannot eat. The patient has reportedly seen many physicians, but she is willing to see more physicians to get to the root of the issue. The patient was recently evaluated by the pediatrician and surgeon again around (b)(6) 2012, and the mother reported that they think the gastroparesis was caused by the damage to the vagus nerve. Follow up with the pediatrician revealed that he did not have any idea if the gastroparesis is a result of possible nerve damage but is treating it as it may be. The patient has impaired gastric emptying, and they recently placed a tube to provide nutrition directly into the large intestine. He did not like this as it would require a pump and cannot provide bolus feeding. He would like for the patient to have a pyloroplasty, however the surgeons do not agree. He stated that vagotomies and pyloroplasties are not often performed any more. He again confirmed that the cause is unknown, but damage to the nerve is being considered as a possibility. He also reaffirmed that the timing is odd. No additional information was provided. Attempts for additional information from the surgeon have been unsuccessful to date.

 
Manufacturer Narrative

 
Manufacturer Narrative

Corrected data: the initial report inadvertently reported the incorrect generator explant date.

 
Event Description

The gastroenterologist confirmed that the patient only recently had gastroparesis that began with the feeding tube issue, as noted by mother.

 
Manufacturer Narrative

Describe event or problem, corrected data: the supplemental report #1 inadvertently did not include this information.

 
Event Description

Additional information was received from the patient's gastroenterologist. He indicated that the gastroparesis was a conclusion the mother came to on her own, and he is not sure what it is related to. The patient only recently began experiencing gastroparesis, but the vns generator was explanted in 2007.

 
Manufacturer Narrative

(b)(4): the initial report did not include the zip code.

 
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Brand NameBIPOL LEAD MODEL 300
Type of DeviceLEAD
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 herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2560609
Report Number1644487-2012-01141
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 04/05/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/04/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2002
Device MODEL Number300-20
Device LOT Number725
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/11/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/28/2000
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: 05/04/2012 Patient Sequence Number: 1
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