SPINALPAK(R) STIMULATOR SOFT-TOUCH ELECTRODES, 72R

Report

Report Number: 0002242816-2017-00030
Event Type: Injury
Date Received: July 17, 2017
Report Date: July 17, 2017
Manufacturer: EBI, LLC.
Product Code: LOF
PMA / PMN Number: PP850022
Removal / Correction Number: N/A
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

FULL PMA/510(K) NUMBER: P850022/S017. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE PRODUCT WAS DISCARDED BY THE PATIENT AND THEREFORE WILL NOT BE RETURNED FOR AN EVALUATION. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. 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.

Description of Event or Problem · 1

THE PATIENT ADVISED THAT HE RECEIVED THE TREATMENT DEVICE ON (B)(6) 2017. TWO WEEKS LATER, HE STARTED BREAKING OUT IN RED, ITCHY HIVES USING THE 72R ELECTRODES WITHOUT COVER PATCHES. THE PATIENT WOULD CHANGE THE ELECTRODES EVERY TWO TO THREE DAYS. THE REDNESS WAS OBSERVED AROUND THE ELECTRODES BUT NOT UNDER THEM. THE PATIENT ADVISED THE HIVES WERE FROM HIS BACK DOWN HIS LEGS. THE PATIENT STATED HE TOOK OVER THE COUNTER BENADRYL ON MEMORIAL DAY WEEKEND BUT IT DID NOT RELIEVE HIS SYMPTOMS. AN HOUR AFTER TAKING THE BENADRYL, HE WENT TO THE EMERGENCY ROOM WHERE THEY ADMINISTERED AN EPI SHOT AND GAVE HIM PREDNISONE TO TAKE. THE PATIENT STATES HE'S SEEN HIS DOCTOR WHO IS NOT SURE WHAT IS CAUSING HIS SYMPTOMS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
498736	SPINALPAK(R) STIMULATOR SOFT-TOUCH ELECTRODES, 72R	STIMULATOR, BONE GROWTH, NON-INVASIVE	LOF	EBI, LLC.	N/A	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention