PULSE GEN MODEL 106

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-27 for PULSE GEN MODEL 106 manufactured by Cyberonics - Houston.

Event Text Entries

[186194529] Clinic notes were received indicating that the patient had some issues with healing at the incision site after a lead and generator replacement. 5 days post-op the patient had extensive swelling and bruising but it was noted that the chest wound was healing well. A month after implant, the patient had issues with swelling and tenderness at the generator and lead incision site. 5 days later, it was noted that the wound was healing satisfactorily and the swelling had diminished with no signs of infection. There was some fluid in the generator site. The visit diagnosis section indicated "nonhealing wound. " clinic notes from a little over two months post-op, indicated that the stitches came out and when one came out his neck pain was better. The notes noted that the wound looked well-healed. Over three months post-op, clinic notes reported that his cervical wound was healing better with still some prominence and tenderness at the infection, but it was noted that there was some drainage from the chest site that the patient described as pus-like. The doctor noted that there was erythema around an apparent suture reaction, but there was no evidence of infection. The area was red but the patient had been rubbing at the site. The patient was prescribed an antibiotic ointment for a potential stitch abscess. A month and a half later it was noted that both wound sites had healed well with no drainage. The manufacturer's device history records were reviewed for the patient's lead and generator. Sterility of both products prior to release was verified. No further relevant information has been received to date.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1644487-2020-00518
MDR Report Key9891718
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2019-06-06
Date Mfgr Received2020-03-03
Device Manufacturer Date2018-10-23
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. RACHEL KOHN
Manufacturer Street100 CYBERONICS BLVD SUITE 600
Manufacturer CityHOUSTON TX 77058
Manufacturer CountryUS
Manufacturer Postal77058
Manufacturer Phone2812287200
Manufacturer G1CYBERONICS - HOUSTON
Manufacturer Street100 CYBERONICS BLVD SUITE 600
Manufacturer CityHOUSTON TX 77058
Manufacturer CountryUS
Manufacturer Postal Code77058
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePULSE GEN MODEL 106
Generic NameGENERATOR
Product CodeLYJ
Date Received2020-03-27
Model Number106
Lot Number5956
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCYBERONICS - HOUSTON
Manufacturer Address100 CYBERONICS BLVD HOUSTON TX 77058 US 77058


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.