MAUDE Adverse Event Report: BIOMET SPINE - BROOMFIELD SPF-XL IIB 2/DM IMPLANTABLE STIMULATOR

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

No device evaluation is able to be performed as the device remains implanted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event, however based on the information provided the pain is due to the patient's si joint.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.

Event Description

The patient reported she had an implantable stimulator implanted in 1997 after l3-l5 fusion.She reports the stimulator has been implanted 18 years although she read in the brochure that "the generator may optionally be removed at the end of its useful life (approximately 24-weeks)." she reports following up with her physician in 2003, however he chose not to remove the device even though she was experiencing pain.She further reports having "other fusions in the cervical area of the spine." she reports seeing a pain management doctor for continuing lower back pain who referred her to a neuro surgeon.She stated the neurosurgeon believes her problem is in her si joint (sacroiliac joint) and is not related to the bone stimulator.She states the surgeon plans to giver her an injection to reduce the swelling; she is unaware of the type of injection and did not have an appointment set at the time.

• Brand Name: SPF-XL IIB 2/DM IMPLANTABLE STIMULATOR
• Type of Device: STIMULATOR
• Manufacturer (Section D): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): BIOMET SPINE - BROOMFIELD; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: michelle cole ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 5311652
• MDR Text Key: 33906587
• Report Number: 3004485144-2015-00115
• 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: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• 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: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 55 YR