Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

MAUDE Adverse Event Report

Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA
 

CYBERONICS, INC. NCP PULSE GENERATOR   Back to Search Results
Model Number 101
Event Date 07/01/2002
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention
Manufacturer Narrative

H. 6. Pt picked at incision site, causing it to open.

 
Event Description

Rptr indicated that pt picked at incision site until it opened. The pt then removed the generator from the pocket. The pt was last seen by physician in 7/02 at which time pt was reportedly healing well. The pt still had their stitches, but there were no signs of infection.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 D)
CYBERONICS, INC.
16511 space center blvd.,
ste. 600
houston TX 77058
Manufacturer Contact
darlene garner, rac
16511 space center blvd.
suite 600
houston , TX 77058
(281) 228 -7200
Device Event Key400202
MDR Report Key411187
Event Key388775
Report Number1644487-2002-00368
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 07/19/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/16/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date02/28/2003
Device MODEL Number101
Device LOT Number4084
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/01/2002
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/19/2002
Was Device Evaluated By Manufacturer? No
Date Device Manufactured09/01/2001
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: 08/16/2002 Patient Sequence Number: 1
#TreatmentTreatment Date
1,MODEL 300-20 NCP BIPOLAR LEAD, EXPIR DATE
2,06/30/2003, DATE OF MFG 07/02/2001, STERILIZATION
3,LOT NO. 3446.
 
-
-
-
-
-