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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Extreme Exhaustion (1843); Nausea (1970); Depression (2361); Numbness (2415); Unspecified Mental, Emotional or Behavioural Problem (4430); Decreased Appetite (4569)
Event Date 01/06/2023
Event Type  malfunction  
Manufacturer Narrative
Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.Health effect - clinical code :e2302.
 
Event Description
The patient reported that after having her settings increased to 2.75ma she experienced neurological issues.She reported that she felt like she was going to have a stroke, her short term memory was affected, her speech slowed, she would fall down, and she struggled to stand on one foot at a time.She said that her physician lowered her to 2.25ma and those issues resolved.The patient believes that her device is not working properly as she only feels good a few days out of the month and the other days she has increased depression and anxiety.She also reported that sometimes when she turns her neck from left to right she feels a flutter like she can feel her blood moving.No other relevant information has been received to date.
 
Event Description
Additional information received noting that the patient had their device disabled and since the disablement, the nausea has subsided and the patient now has their appetite again and energy.
 
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Brand Name
PULSE GEN MODEL 106
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key16283383
MDR Text Key308631584
Report Number1644487-2023-00109
Device Sequence Number1
Product Code MUZ
UDI-Device Identifier05425025750061
UDI-Public05425025750061
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 Consumer
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/09/2023
Device Model Number106
Device Lot Number205729
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 01/06/2023
Initial Date FDA Received02/02/2023
Supplement Dates Manufacturer Received02/14/2023
Supplement Dates FDA Received03/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/27/2021
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 Outcome(s) Other;
Patient Age63 YR
Patient SexFemale
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