MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INC. FREEDOM NEUROSTIMULATOR; SPINAL CORD STIMULATOR

Model Number FR8A-TRL-A0, FR8A-TRL-B0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

The therapy specialist witnessed the anesthesiologist begin intravenous sedation and antibiotic administration, and immediately following the sedation the patient's blood pressure dropped and became unstable.The anesthesiologist immediately began taking measures to re-stabilize the patient.The therapy specialist reported that the anesthesiologist and implanting clinician determined the case could continue approximately one (1) hour after the patient became unstable.The implanting clinician proceeded with the case and implanted both trial stimulators in approximately fifteen (15) minutes, but the devices were never turned on.The therapy specialist left the operating room and waited for approximately one (1) hour for the patient to be brought back to the post procedure recovery room for programming.A nurse later informed the therapy specialist that the patient was transferred to another nearby hospital for additional medical attention.On the morning of (b)(6) 2018, the therapy specialist spoke with the patient's daughter and was informed that the patient passed away the previous night.The therapy specialist witnessed the anesthesiologist begin intravenous sedation and antibiotic administration, and immediately following the sedation the patient's blood pressure dropped and became unstable.The anesthesiologist immediately began taking measures to re-stabilize the patient.The therapy specialist reported that the anesthesiologist and implanting clinician determined the case could continue approximately one (1) hour after the patient became unstable.The implanting clinician proceeded with the case and implanted both trial stimulators in approximately fifteen (15) minutes, but the devices were never turned on.The therapy specialist left the operating room and waited for approximately one (1) hour for the patient to be brought back to the post procedure recovery room for programming.A nurse later informed the therapy specialist that the patient was transferred to another nearby hospital for additional medical attention.On the morning of (b)(6) 2018, the therapy specialist spoke with the patient's daughter and was informed that the patient passed away the previous night.Patient death is unrelated to the product, based on this information, the patient death was confirmed , there is no evidence that product did not meet specification and the stimulator is used for treatment of pain.Dhr was not reviewed as this was not attributed to the product.The device was never powered on and was not in use when the issue occurred.

Event Description

Stimwave quality has investigated the details surrounding a complaint resulting from a death not related to device use or malfunction of a stimq trial pns stimulator reported on (b)(6) 2018, by stimwave therapy specialist.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• Manufacturer (Section G): STIMWAVE TECHNOLOGIES INC.; 1310 park central boulevard s.; pompano beach,
• Manufacturer Contact: luis fontaneda ; 1310 park central boulevard s.; pompano beach,
• MDR Report Key: 10424439
• MDR Text Key: 203455650
• Report Number: 3010676138-2020-00106
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170141
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2019
• Device Model Number: FR8A-TRL-A0, FR8A-TRL-B0
• Device Lot Number: SWO170822, SWO170822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 93 YR