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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR

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CYBERONICS - HOUSTON PULSE GEN MODEL 102 GENERATOR Back to Search Results
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/29/2006
Event Type  Injury  
Event Description

It was reported by the caregiver that the patient's implant site was so swelled up after the generator replacement surgery that the patient was hospitalized overnight, even though it was originally supposed to be an outpatient procedure. The caregiver reported that a week later it was still swollen and they stuck it with a needle, expecting fluid to drain out, but nothing came out. The caregiver stated that the surgeon had "no idea what the swelling was about and to this day doesn't know".

 
Manufacturer Narrative

Report source, corrected data: initial report inadvertently selected other and input 'caregiver' instead of selecting consumer.

 
Event Description

It was reported via clinic notes that after a period of time following the surgery, fluid was extracted from around the wound site and was sent to the lab for evaluation of the cultures. It was noted that the swilling was nonpurulent and there was no drainage nor had the patient been having any fever. Clinic notes from a later date indicated that both incisions were in very good condition and there was no fluctuance, redness, or apparent tenderness. The surgical notes indicated that the incision sites were irrigated with bacitracin solution.

 
Manufacturer Narrative

Describe event or problem, corrected data: follow-up report #01 inadvertently left out the information regarding the reported hematoma. (b)(4).

 
Event Description

The clinic notes received also contained notes from a second physician that indicated that the patient had a hematoma that was beneath the patient's skin, not the pectoral muscle, that was still quite apparent. It was noted that the yellowish discoloration had spread over the chest, down to the left elbow and over the clavicle. It was noted that the hematoma area was fluctuant, but did not feel hot and was not tender. The physician attempted to aspirate the area was only able to aspirate only 2 to 3 cc of blood, which was sent for culture. It is unclear if the reference of swelling from one physician was the same as hematoma referenced by the second physician.

 
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Brand NamePULSE GEN MODEL 102
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6808989
Report Number1644487-2017-04335
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial
Report Date 10/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/21/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2007
Device MODEL Number102
Device LOT Number015030
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/04/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2006
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: 08/21/2017 Patient Sequence Number: 1
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