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

Model Number N/A

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Improper or Incorrect Procedure or Method (2017)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Event Description

The sales associate reports fitting the patient with the bone growth stimulator on (b)(6) 2015, he later received a call from the patient stating that he had read through some of the pamphlets and he read that this device is not to be used for patients with a pacemaker.The sales associate asked the patient to discontinue using the device until he consulted his cardiologist.At the time of the phone call the patient did not report experiencing any negative reactions to the device.The sales associate asked the patient to call him next week after speaking with his doctor.The sales associate reports he spoke to the patient on tuesday (b)(6) 2015, at this time the patient alleges "that the device had caused his pacemaker to malfunction and that he experienced an electric current all over his body due to use of the device.He also stated that his doctor forgot he had a pacemaker when he prescribed the bone simulator, he also made statements they he may need to have his pacemaker replaced now.".

Manufacturer Narrative

The contraindications for the device state "under certain conditions, electromagnetic stimulation generated by a bone healing system could inhibit the output of some demand pacemakers or implantable defibrillators.Therefore, it is not recommended for patients with certain types of pacemakers or implantable defibrillators.Patients should be cautioned to avoid coming in close proximity to pacemaker or defibrillator wearers during stimulation treatment." without a product return, no product evaluation is able to be conducted.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: BIOMET EBI BONE HEALING SYSTEM
• Type of Device: NON-INVASIVE BONE GROWTH 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: 4950476
• MDR Text Key: 6251800
• Report Number: 0002242816-2015-00077
• Device Sequence Number: 1
• Product Code: LOF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP790002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2015
• 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: 1068234
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other