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

Model Number	FR8A-RCV-A0, FR8A-SPR-B0
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	03/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported an infection and erosion of both stimulators.An explant procedure was performed on (b)(6) 2022.The patient is doing well and no further issues have been reported.
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, implanting damaged devices, implanting expired devices, not prepping the skin with antiseptic solution, not irrigating the incision site, using inappropriate tools and multiple tunneling attempts have been ruled out as potential causes.However, the questionnaire shows the implanting clinician did not follow ifu when creating the receiver pocket and no anchoring devices were used.The questionnaire shows patient had an mri.However, the mri was performed after the erosion and there were no adverse events associated with the mri.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.The cause of the erosion is due to inadequate fixation as the clinician did not create subcutaneous receiver pocket, tie knots, coil receiver, suture, and knot around the coil or use an anchoring device (user error - clinician).
Event or Problem Description
The patient reported an infection and erosion of both stimulators.An explant procedure was performed on (b)(6) 2022.The patient is doing well and no further issues have been reported.
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, implanting damaged devices, implanting expired devices, not prepping the skin with antiseptic solution, not irrigating the incision site, using inappropriate tools and multiple tunneling attempts have been ruled out as potential causes.However, the questionnaire shows the implanting clinician did not follow ifu when creating the receiver pocket and no anchoring devices were used.The questionnaire shows patient had an mri.However, the mri was performed after the erosion and there were no adverse events associated with the mri.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.The cause of the erosion is due to inadequate fixation as the clinician did not create subcutaneous receiver pocket, tie knots, coil receiver, suture, and knot around the coil or use an anchoring device (user error - clinician).Corrected data: e3 occupation was corrected from a blank selection to non-healthcare professional.D4 unique identifier (udi) # was corrected to include all parentheses and symbols.
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, implanting damaged devices, implanting expired devices, not prepping the skin with antiseptic solution, not irrigating the incision site, using inappropriate tools and multiple tunneling attempts have been ruled out as potential causes.However, the questionnaire shows the implanting clinician did not follow ifu when creating the receiver pocket and no anchoring devices were used.The questionnaire shows patient had an mri.However, the mri was performed after the erosion and there were no adverse events associated with the mri.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.The cause of the erosion is due to inadequate fixation as the clinician did not create subcutaneous receiver pocket, tie knots, coil receiver, suture, and knot around the coil or use an anchoring device (user error - clinician).Corrected data: d1 and d2: brand name and common device name.E: initial reporter information.G4: pma/510(k) number.
Event or Problem Description
The patient reported an infection and erosion of both stimulators.An explant procedure was performed on (b)(6), 2022.The patient is doing well and no further issues have been reported.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Common Device Name: SPINAL CORD STIMULATOR
• 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: 14164035
• Report Number: 3010676138-2022-00050
• Device Sequence Number: 14526327
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)210201(01)00818225020648(17)211201(21)211257-69
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/16/2022

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 Expiration Date: 02/01/2021
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO190202, SWO191202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Supplement Date Received by Manufacturer: 03/22/2022; 03/22/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/10/2022; 06/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown