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

Model Number FR8A-RCV-A0, FR8A-SPR-B0

Device Problem Material Erosion (1214)

Patient Problem Skin Infection (4544)

Event Date 03/15/2022

Event Type  Injury  

Event 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.

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 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.

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.

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 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
• Type of Device: 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
• MDR Text Key: 289723170
• Report Number: 3010676138-2022-00050
• Device Sequence Number: 1
• 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
• Reporter Country Code: US
• PMA/PMN Number: K182720
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention