FDA.reportPublic FDA data

MAUDE MDR 9868255

MDR report key
9868255
Report number
1644487-2020-00493
Event key
0
Event type
3
Date of event
2020-03-27
Date received
2020-03-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. RACHEL KOHN
Address
100 CYBERONICS BLVD SUITE 600 HOUSTON TX 77058 US
Phone
281-281-2812
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PULSE GEN MODEL 1000GENERATORCYBERONICS - HOUSTONLYJ1000205012N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2301. O; 2. R

Event Narratives#

N

Patient 1

DEVICE EVALUATED BY MFR? DEVICE EVALUATION IS NOT NECESSARY AS THE WOUND DEHISCENCE IS NOT RELATED TO THE FUNCTIONALITY OR DELIVERY OF THERAPY OF THE DEVICE.

D

Patient 1

IT WAS REPORTED THAT SINCE A PATIENT'S GENERATOR WAS PLACED IN AXILLARY REGION, THE PATIENT'S CHEST INCISION SPLIT OPEN DUE TO ACTIVITY. THE PATIENT'S GENERATOR WAS EXPLANTED. DEVICE HISTORY RECORDS WERE REVIEWED FOR THE GENERATOR AND THE DEVICE PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. NO ADDITIONAL RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.