MAUDE Adverse Event Report: DJO CMF SPINALOGIC ; BONE GROWTH STIMULATOR

Model Number 01-207-0007

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Muscle Spasm(s) (1966); Pain (1994); Myalgia (2238); Discomfort (2330)

Event Date 02/04/2016

Event Type  Injury  

Event Description

I was prescribed the spinalogic bone growth stimulator for use 2 weeks after a transpedicular thoracic discectomy, laminectomy and fusion with instrumentation due to spinal cord encroachment.I was to use the device for the pre-programmed 30 minutes per day for a maximum of 9 months.I used the device the first day with moderate discomfort but no outright pain.The second day my back started to hurt severely after about 15 minutes and i had to take it off at 20 minutes.My back remained painful and i spasm for about 3 hours after using the device.The next day i tried it again with the intent to take it off early if necessary.It hurt immediately, and i only made it to 15 minutes having tried several positions, loosening it, repositioning it and padding it.Again, i remained in significant pain for 3 hours after removing it.I notified the company rep and my physician of the problem, and that i would not be able to continue the treatment due to severe pain during the treatment.I was on prescribed post-operative norco 7.5/325, lyrica for nerve pain and baclofen for muscle spasms during the treatment with the device and still had the pain and spasms.In addition to the treated herniated disc.I am diagnosed with multiple sclerosis, muscle spasms and fibromyalgia.

• Brand Name: SPINALOGIC
• Type of Device: BONE GROWTH STIMULATOR
• Manufacturer (Section D): DJO CMF
• MDR Report Key: 5427618
• MDR Text Key: 38010474
• Report Number: MW5060071
• Device Sequence Number: 1
• Product Code: LOF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 01-207-0007
• Device Catalogue Number: 01-207-0007
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 86