MAUDE Adverse Event Report: BIOMET EBI SPF-PLUS 60/M, 60 MICRO AMPS; SPINAL STIMULATOR

Model Number SPF-PLUS 60/M

Device Problems Power Conditioning Problem (1474); Inadequate Lighting (2957)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/02/2014

Event Type  malfunction  

Event Description

Biomet ebi spf-plus 60/m implantable spinal stimulator was opened but not working (light did not turn on).Device was removed from the field (not implanted).A second stimulator was opened and worked without problem.Biomet representative (b)(4) present.Diagnosis or reason for use: chronic pain management.

• Brand Name: EBI SPF-PLUS 60/M, 60 MICRO AMPS
• Type of Device: SPINAL STIMULATOR
• Manufacturer (Section D): BIOMET; parsippany NJ 07054
• MDR Report Key: 3732773
• MDR Text Key: 4322804
• Report Number: MW5035501
• 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: Nurse
• Type of Report: Initial
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2014
• Device Model Number: SPF-PLUS 60/M
• Device Catalogue Number: 10-1398M
• Device Lot Number: 406402
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR