MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. STIMQ NEUROSTIMULATOR; WEARABLE ANTENNA ASSEMBLY

Model Number	PDBT-915-2K
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Both wearable antenna assembly units associated with this mdr were not used when the occurrence took place.The procedure was performed according to the ifu.In addition, the stimulators with the system: were not implanted at an off-label location.Were not implanted too close to the targeted nerve.Migration did not occur.Bone or tissue was not inadvertently punctured during the procedure.The waas associated with this complaint ( (b)(4) ) were returned for investigation.The investigations concluded that the units performed as expected and no issues were found.A stimwave representative conducted a review of sterilization and packaging records for the respective product lot; stimwave has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator is used to treat pain.Based on this objective evidence, the cause of the death is unknown and unrelated to the stimwave products (no problem/fault found).
Event or Problem Description
The patient died of natural causes on (b)(6) 2021.There were no issues reported with the stimwave products.The patient's wife would like to return both wearable antenna assembly units.

• Brand Name: STIMQ NEUROSTIMULATOR
• Common Device Name: WEARABLE ANTENNA ASSEMBLY
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064
• MDR Report Key: 12804838
• Report Number: 3010676138-2021-00227
• Device Sequence Number: 20211704
• Product Code: GZF
• UDI-Device Identifier: 00818225020150
• UDI-Public: 0100818225020150
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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: Lay User/Patient
• Device Model Number: PDBT-915-2K
• Device Lot Number: 00443-LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STIMQ NEUROSTIMULATOR, SN: (B)(4), LN:SWO190904; STIMQ NEUROSTIMULATOR, SN: (B)(4), LN:SWO191202; WAA (PDBT-915-2K), SN: 6827190B2C1A
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown