MAUDE Adverse Event Report: EBI, LLC. SPF SPINAL FUSION STIMULATOR; IMPLANTABLE STIMULATOR

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 03/19/2015

Event Type  Injury  

Event Description

The original surgery was performed (b)(6) 2014 and a implantable stimulator was placed.The patient reported having an mri on (b)(6) 2014; he states the radiologist informed him that he never performed an mri with this stimulator and advised the patient to hit the button if he felt anything.The patient said he could not feel any pain during the mri, however a couple days later he began experiencing pain and electrical shock sensation.The patient followed up with his physician who subsequently explanted the stimulator on (b)(6) 2015.The patient reports the symptoms subsided after the device was explanted.

Manufacturer Narrative

The package insert has a section titled "mri safety information, artifacts testing and efficacy" which has instructions for mri procedures and states "the effects of mri procedures using mr systems and conditions above these levels have not been determined." review of device history records show that lot released with no recorded anomaly or deviation.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

• Brand Name: SPF SPINAL FUSION STIMULATOR
• Type of Device: IMPLANTABLE STIMULATOR
• Manufacturer (Section D): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 399 jefferson road; parsippany NJ 07054
• Manufacturer Contact: michelle cole ; 399 jefferson road; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 4879042
• MDR Text Key: 6059237
• Report Number: 0002242816-2015-00064
• Device Sequence Number: 1
• Product Code: LOE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP850035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/02/2015

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10-1335M
• Device Lot Number: 221475
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention