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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 1000; GENERATOR Back to Search Results
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446); No Information (3190)
Event Date 12/08/2020
Event Type  Injury  
Event Description
It was reported the patient was scheduled for wound revision surgery.The cause for the surgery was not reported.Device history record was reviewed for both the generator and lead.Both devices were sterilized prior to distribution, and no unresolved nonconformances were identified prior to distribution.No additional relevant information has been received to date.No known surgical intervention has occurred to date.
 
Event Description
Per the physician, the patient was experiencing wound deheisence.It was noted that while removing the patient's shirt, a band-aid was inadvertently peeled off over the incision/skin glue.It was noted the patient had ripped his wound dressing the second day after the surgery.The band-aids were used to cover the incision to prevent the patient from touching the incision.The physician noted that wound picking and suboptimal wound care with band-aids may have led to the premature removal of the skin glue resulting in wound deheisence.The area of wound dehiscence (-1cm) was carefully inspected and visible subcutaneous stitches were noted, but no visibly exposed hardware.The electrode could be palpated under this location.To improve healing of the site and minimize risks of infection, the decision was made to reposition the electrode and revise the wound without underlying hardware.No additional relevant information has been received to date.
 
Manufacturer Narrative
H3.Device evaluated by mfr?, code 81, device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
Patient had a generator explant.Leads were left implanted.It was stated the wound exploration surgery was due to infection.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No additional relevant information has been received to date.
 
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Brand Name
PULSE GEN MODEL 1000
Type of Device
GENERATOR
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
MDR Report Key11091586
MDR Text Key224246007
Report Number1644487-2020-01747
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750405
UDI-Public05425025750405
Combination Product (y/n)N
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 06/07/2021
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? No
Device Operator Lay User/Patient
Device Expiration Date07/29/2022
Device Model Number1000
Device Lot Number205390
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received12/29/2020
Supplement Dates Manufacturer Received12/28/2020
05/13/2021
Supplement Dates FDA Received01/22/2021
06/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age16 YR
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