MAUDE Adverse Event Report: EBI, LLC. SPF SPINAL FUSION STIMULATOR; IMPLANTABLE STIMULATOR; SPF-XL IIB 2/DM

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 06/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is reported the device was discarded, therefore no product will be returned to the manufacturer.Based on the information provided the device was removed as a precautionary measure.If additional information is obtained that adds value to the relevant content of this report a follow-up report will be sent.

Event Description

It was reported when the patient came back into the office on (b)(6) 2017 the surgeon removed the spf device as a precautionary measure due to the receipt of a recall notice (zfa 2017-245).The battery and leads were explanted and disposed of.

• Brand Name: SPF SPINAL FUSION STIMULATOR
• Type of Device: IMPLANTABLE STIMULATOR; SPF-XL IIB 2/DM
• 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: 6690971
• MDR Text Key: 79229095
• Report Number: 0002242816-2017-00026
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2018
• Device Model Number: N/A
• Device Catalogue Number: 10-1335M
• Device Lot Number: 585-17
• Other Device ID Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: ZFA 2017-245
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention