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

Model Number SHRK-ALL-1K

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Skin Erosion (2075)

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

The patient has been scheduled for a revision on (b)(6) 2021, to correct the erosion.The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting a non-sterile device, implanting an expired device, not using antibiotics, using inappropriate tools, patient engaging in strenuous activities, the patient picking or touching the wound, and multiple tunneling attempts have been ruled out as potential causes.The questionnaire shows the clinical representative is unsure if tools were switched during the procedure and the stimulator was anchored at pocket but not entry, potentially contributing to the occurrence.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 depth (user error-clinician).

Event Description

Patient had to undergo revision due to implanted device eroding through skin.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: SPINAL CORD NERVE 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: andrea najera ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 12322260
• MDR Text Key: 266563533
• Report Number: 3010676138-2021-00172
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2021
• Device Model Number: SHRK-ALL-1K
• Device Catalogue Number: SA-0001
• Device Lot Number: 10712
• Date Manufacturer Received: 07/15/2021
• 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