MAUDE Adverse Event Report: EBI, LLC. SPINALPAK(R) STIMULATOR; STIMULATOR, BONE GROWTH, NON-INVASIVE

Model Number N/A

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

Patient Problem Palpitations (2467)

Event Type  Injury  

Manufacturer Narrative

The warnings in the package insert state, "cardiac pacemakers or cardioverters may be adversely affected by the biomet® spinalpak® stimulator.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® stimulator device.If there are any observable adverse changes in the pacemaker rhythm or output, the device should not be used." 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 a follow-up report will be sent.

Event Description

The patient advised she has a pacemaker and was cleared by her cardiologist to use the device.Prior to the application of the device, the cardiologist advised the patient that if she experienced any adverse effects to stop using the device.On the first day the patient used the device, she experienced heart palpitations.The patient stopped using the device after that experience.

Manufacturer Narrative

Review of the device history records shows the lot was released with no recorded anomaly or deviation.

Manufacturer Narrative

A visual inspection of the returned system was performed.It was received in a shipping spare part box and seems to be in good physical condition from the cosmetic/visual point of view.Visual inspection to the unit, charger, ac adapter, both batteries and both lead wires was performed and doesn't exposed wiring was observed.Further review of other component received as sp unit, charger, ac adapter, both cable assemblies and both batteries confirmed they operated/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.The notification date for this event is mar 1, 2017.

• Brand Name: SPINALPAK(R) STIMULATOR
• 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: 6424270
• MDR Text Key: 70555641
• Report Number: 0002242816-2017-00009
• 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: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2017
• 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: 1067716
• Device Lot Number: N/A
• Other Device ID Number: (01)00812301020218(21)L35266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2016
• 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