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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER

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CYBERONICS - HOUSTON PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER Back to Search Results
Model Number TABLET HP
Device Problems Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/21/2020
Event Type  malfunction  
Manufacturer Narrative
Voluntary medical device correction (remedial action) was initiated by the manufacturer on (b)(6) 2020, and the physician was provided a notification letter with recommended actions.Internal reference number: (b)(4).
 
Event Description
After the patients replacement surgery, the device was turned off and on a few times, and a current not delivered message was received at one point.Internal testing and data review identified that false low output current messages can occur when m3000 v1.6 software programs a m103-106 generator after a specific programming sequence occurs.When m3000 v1.6 tablets initiate a programming session with a m103-106 generator, where its output current is programmed off (0 ma), and then the output current is programmed back on to >0 ma, a low output current message would be seen when an in-session interrogation is performed.This would persist upon multiple in-session interrogations and if diagnostics werent performed during the session, show on the session report.Running system diagnostics or ending and restarting the session will confirm functionality of the device, and resolve the ¿output current low¿ error message.The low output current messages in these cases are false and do not impact generator function.Based on the reported programming sequence that occurred that day, it was consistent with the false low output current mechanism described above.Therefore, the patient's generator is expected to be able to deliver therapy as programmed.No further relevant information has been received to date.
 
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Brand Name
PROGRAMMING SOFTWARE
Type of Device
PROGRAMMING COMPUTER
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
rachel kohn
100 cyberonics blvd
suite 600
houston, TX 77058
2812287200
MDR Report Key10839770
MDR Text Key216946604
Report Number1644487-2020-01535
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750535
UDI-Public05425025750535
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Remedial Action Notification
Type of Report Initial
Report Date 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberTABLET HP
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 10/21/2020
Initial Date FDA Received11/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age38 YR
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