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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR
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NALU MEDICAL INC NALU NEUROSTIMULATION SYSTEM; PERIPHERAL NERVE STIMULATOR Back to Search Results
Model Number 71004
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/21/2021
Type of Reportable Event Serious Injury
Event or Problem Description
On x-ray, it was found that the ipg migrated causing loss of communication with the therapy discs.Revision to move the ipg was performed.The original implant was moved to a new pocket.No further communication issues have been reported.
 
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Brand Name
NALU NEUROSTIMULATION SYSTEM
Common Device Name
PERIPHERAL NERVE STIMULATOR
Manufacturer (Section D)
NALU MEDICAL INC
2320 faraday avenue,suite #100
carlsbad CA 92008 7241
MDR Report Key12333354
Report Number3015425075-2021-00009
Device Sequence Number17253639
Product Code GZF
UDI-Device Identifier00812537030524
UDI-Public01008125370305241120012317210122
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K183579
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/21/2021
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
Operator of Device Health Professional
Device Expiration Date01/22/2021
Device Model Number71004
Device Catalogue Number71004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/21/2021
Initial Report FDA Received Date08/17/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		N/A
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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