MAUDE Adverse Event Report: EBI, LLC. SPINALPAK STIMULATOR

Model Number N/A

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

Review of device history records show the lot released with no recorded anomaly or deviation.Without a product return, no product evaluation is able to be conducted.The warnings in the product manual state "do not short circuit, overcharge, crush, mutilate, nail penetrate, heat, reverse the + or ¿ terminals or disassemble the battery pack.Do not allow metal objects to come into contact with the battery pack terminals.These and any other abuses of the battery pack may cause serious injury and/or burns.To ensure proper charging and safety, use only the charger supplied with your device.Keep battery pack dry." current information is insufficient to permit a valid conclusion about the cause of this event.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 when the battery gets low, one bar remaining, the unit shocks him.He states it feels like electricity in his leg and a lightening bolt through his toe.

• Brand Name: SPINALPAK STIMULATOR
• Type of Device: SPINALPAK 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
• MDR Report Key: 5904304
• MDR Text Key: 53006797
• Report Number: 0002242816-2016-00021
• 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
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• 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)00888480587903(21)L24185
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2016
• 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