MAUDE Adverse Event Report: STIMWAVE TECHNOLOGIES INCORPORATED FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELI

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Rash (2033); Therapeutic Response, Decreased (2271)

Event Date 03/15/2019

Event Type  Injury  

Event Description

Pt reported that he contacted stimwave technologies incorporated to locate a physician that would implant the freedom spinal cord stimulator (scs) system.He was provided a surgeon in (b)(6) he stated that the surgeon informed him that he would be able to implant the permanent system, but he does not implant the trial implant.The surgeon provided him a pain specialist that would implant the trial and told him that he was to return once the trial was over.On (b)(6) 2018 the pain specialist implanted the trial system.The pt stated that on the way home he began to bleed at the incision site.He went back to the dr's office and the bandage was removed and the dr applied pressure to the wound for 20 mins.The dr told him that the reason he had the bleeding was due to a rash he had previously.(the pt notes that he informed the dr that he was scheduled for a different diagnostic exam in (b)(6) 2018 and the anaesthesiologist refused to proceed because of that same rash.He alleges that the pain dr told him that it would be ok to have the trial implant with the rash).Once the bleeding subsided the pt was released, and no further issues occurred with the trial implant.Approx a week later, the trial was removed, and the pain dr scheduled the surgery for the permanent system on (b)(6) 2018.He went in for a f/u on (b)(6) 2019.When the nurse practitioner pulled back the bandage, the right lead had popped out and had protruded by 3 mm.The dr insisted on a revision, but the pt stated that he did not want to have a revision due to the cost.The billing office assured him that there would be no cost at that time.The pt stated he still had reservations as the post-surgical instructions were not to bathe.He was afraid that he would get an infection as he had a history of (b)(6).The dr assured him that he would not do a full replacement and only a revision under a local anesthetic.He was scheduled for the revision on (b)(6) 2018.Upon the revision, he alleged that he was given an iv and "knocked out." he didn't know what happened but work up with a bandage.On (b)(6), he returned for his f/u appt.He stated that he asked the np what happened during the revision and he was told that he had a replacement of the right lead.He stated that his medical records also confirm this.When the np pulled back the bandage she said it appeared that he had an infection.She asked the dr to look at it and he said that it was infected and he would need an extraction.The pt requested a culture of the site and was scheduled for the extraction the next day.After the extraction he alleges that the over night lab results came back inconclusive because the wrong swab was used.According to the pt they were never able to confirm an infection and once the right lead was extracted, the left never worked properly again.At that point the pt stated he lost confidence in the device and the pain dr, and went back to the surgeon.He requested that the surgeon to remove the left lead.It was explanted was (b)(6) 2018.Pt stated that the system only worked a total of 5 times the entire time he had it.

Event Description

Add'l info received from reporter on 07/02/2019 for report mw5087567.Pt stated that on (b)(6) 2019 when his permanent system was implanted, there was the mfr rep present providing instruction to the pain specialist as if it were his first time inserting the device.The pt reports that the pain specialist made a comment that there was a problem with the particular way he was instructed to stitch the lead.He stated that the stitch was faulty.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELI
• Manufacturer (Section D): STIMWAVE TECHNOLOGIES INCORPORATED
• MDR Report Key: 8727532
• MDR Text Key: 149477862
• Report Number: MW5087567
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR
• Patient Weight: 86