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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC.NCP PULSE GENERATOR

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CYBERONICS, INC. NCP PULSE GENERATOR   Back to Search Results
Model Number 101
Event Date 01/11/2002
Event Type  Injury   Patient Outcome  Required Intervention,Hospitalization
Event Description

Rptr indicated that pt had explanted self. It was reported that the pt went into the restroom and when the pt came out, the generator was out of the pt's chest. The pt opened the healed incision. The pt had apparently pried the generator out with the pt's hands. The pt picked at it until the pt got it out. The pt's lead was explanted by surgeon and the pt was prescribed a prophylactic ten-day dose of amoxicillin. There are no plans for re-implant. Further f/u revealed that the pt was seen in 2002 at which time the pt's staples were removed and the pt was reported to be healing fine from the explant procedure. No further appointments are scheduled.

 
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Brand NameNCP PULSE GENERATOR
Type of DevicePULSE GENERATOR
Baseline Brand NameNCP PULSE GENERATOR
Baseline Generic NamePULSE GENERATOR
Baseline Catalogue NumberNA
Baseline Model Number101
Baseline Device FamilyNA
Baseline Device PMA NumberP970003
Baseline Shelf Life Information Yes
Is Baseline 510(K) Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)18
Date First Marketed02/01/2000
Manufacturer (Section F)
CYBERONICS, INC.
16511 space center blvd., #600
houston TX 77058
Manufacturer (Section D)
CYBERONICS, INC.
16511 space center blvd., #600
houston TX 77058
Manufacturer Contact
darlene garner, rac
16511 space center blvd.
ste. 600
houston , TX 77058
(281) 228 -7200
Device Event Key366684
MDR Report Key377618
Event Key356372
Report Number1644487-2002-00055
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 01/16/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/18/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date11/30/2002
Device MODEL Number101
Device LOT Number3071
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/01/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/16/2002
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/2001
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/18/2002 Patient Sequence Number: 1
#TreatmentTreatment Date
MODEL 300-30 NCP BIPOLAR LEAD,
EXPIRE DATE 1/31/2002, DATE OF MFG 12/22/1999,
STERILIZATION LOT NO. 32937C.
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