MAUDE Adverse Event Report: EBI, LLC. ORTHOPAK STIMULATOR, BIOMET; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number N/A

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

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Manufacturer Narrative

Review of the device history records shows the lot was released with no recorded anomaly or deviation.The patient manual states "cardiac pacemakers or cardioverters may be adversely affected by the biomet® spinalpak® non-invasive spine fusion stimulator system.The concomitant use of the device and a pacemaker or cardioverter must be assessed on an individual basis, such as with an electrocardiogram, prior to use.The patient should be referred to a cardiologist for monitoring of pacemaker function while wearing the active biomet® spinalpak® non-invasive spine fusion stimulator system.If there are any observable adverse changes in the pacemaker rhythm or output, the biomet® spinalpak® non-invasive spine fusion stimulator system should not be used." a follow up report will be sent upon completion of the device evaluation.

Event Description

The patient advised her sales representative that her blood pressure "shot up" in the middle of the night on her first night of using the stimulator.The patient's cardiologist advised the patient to stop using the stimulator.No treatments were administered and no medication was prescribed to the patient.

Manufacturer Narrative

A visual inspection was performed; the product seems to be in good physical condition from the cosmetic/ visual point of view and no exposed wiring was observed.Review of the controller data was performed and the treatment hours indicates the unit treated for 0 days, 9 hours and 57 minutes.The product was tested and found to function as intended.No physical and/or functional condition could be found that could be considered a causal factor for the reported complaint.The reported claim could be associated with a side effect / clinical condition of the patient which is unknown.The reported condition is related to clinical factors beyond the scope of the device investigation covered in the complaint investigation.

• Brand Name: ORTHOPAK STIMULATOR, BIOMET
• Type of Device: STIMULATOR, BONE GROWTH, NON-INVASIVE
• 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: 6549224
• MDR Text Key: 74555382
• Report Number: 0002242816-2017-00017
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP850022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1067719
• Device Lot Number: N/A
• Other Device ID Number: (01)00812301020232(21)T23322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other