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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATION
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NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; SPINAL CORD STIMULATION Back to Search Results
Model Number 71005
Device Problem Migration (4003)
Patient Problem Weight Changes (2607)
Event Date 08/07/2020
Event Type  Injury  
Event Description
Patient was initially implanted on (b)(6) 2020.On (b)(6) 2020 an ultrasound revealed device migration.Subsequent revision surgery occurred on (b)(6) 2020.
 
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Brand Name
NALU NEUROSTIMULATION SYSTEM
Type of Device
SPINAL CORD STIMULATION
Manufacturer (Section D)
NALU MEDICAL INC
2320 faraday avenue
suite 100
carlsbad, ca
Manufacturer (Section G)
NALU MEDICAL INC.
2320 faraday avenue
suite 100
carlsbad, ca
Manufacturer Contact
terry villarba
2320 faraday avenue
suite 100
carlsbad, ca 
4482360
MDR Report Key10466054
MDR Text Key204750841
Report Number3015425075-2020-00010
Device Sequence Number1
Product Code GZB
UDI-Device Identifier00812537033600
UDI-Public01008125370336001119121617201215
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/15/2020
Device Model Number71005
Device Catalogue Number71005
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/16/2019
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 Outcome(s) Other;
Patient Age67 YR
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