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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Muscle Weakness (1967); Discomfort (2330)
Event Date 04/21/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had left arm pain after a lead and generator revision.The pain started 6 days post-surgery.The patient was admitted to hospital with worsening neurogenic pain over 2 weeks.He was hyperaesthetic over the left upper limb with no dermatomal distribution.He had mild weakness in the c7 muscles (wrist extension and elbow extension).It was noted that the possible diagnoses were brachial plexopathy related to surgery( bleeding or inflammation), reactive brachial plexopathy, or a new c6/7 disc causing radiculopathy.A ct scan shoed edema around the sternocleidomastoid muscle and mild left c6/7 foramina stenosis.There was no swelling or hematoma around the brachial plexus.The patient was started on gabapentin and showed some improvement in the pain.He left the hospital and was improving.No further relevant information has been received to date.
 
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Brand Name
LEAD MODEL 304
Type of Device
LEAD
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
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key11931541
MDR Text Key254062688
Report Number1644487-2021-00752
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750139
UDI-Public05425025750139
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,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 06/03/2021
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 Model Number304-20
Device Lot Number6742
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 05/12/2021
Initial Date FDA Received06/03/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/16/2020
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) Hospitalization; Required Intervention;
Patient Age51 YR
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