FDA Adverse Event Injury Summary report: N

SPNIAL CORD STIMULATOR

MDR report key: 3872191 · Received June 9, 2014

Report

Report Number
MW5036565
Event Type
Injury
Date Received
June 9, 2014
Date of Event
May 28, 2014
Report Date
June 6, 2014
Manufacturer
BOSTON SCIENTIFIC
Product Code
LGW
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
AL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

I HAVE CHRONIC AND SEVERE OCCIPITAL NEURALGIA. I HAD A SPINAL CORD STIMULATOR IMPLANTED IN 2009. THE STIMULATOR IS NOT WITHIN THE SPINAL CORD, BUT UNDER THE SKIN. THE BATTERY IS AT MY RIGHT HIP. A CONNECTOR IS IN THE MIDDLE OF MY BACK AND ANOTHER IS AT THE BASE OF MY SPINE. THERE IT SPLITS, WITH LEADS GOING UP UNDER MY SCALP ON THE LEFT AND THE RIGHT. BEGINNING IN LATE 2013, THE AREA AT THE BASE OF MY NECK WHERE THE CONNECTOR IS SHOCKS ME, STINGING AND BURNING, IF I MOVE A CERTAIN WAY. I REPORTED THIS TO MY LOCAL REPRESENTATIVE, (B)(4) IN (B)(6) 2014. (MY HUSBAND WAS IN THE HOSPITAL AND A REHABILITATION FACILITY, SUFFERING FROM TERMINAL CANCER, FROM (B)(6), WHEN HE PASSED AWAY.) I MET WITH ANOTHER REPRESENTATIVE OF BOSTON SCIENTIFIC IN THE OFFICES OF DR (B)(6) ON (B)(6) 2014. HE CHANGED THE STIMULATION SETTINGS AND USED DR (B)(6) EQUIPMENT TO PHOTOGRAPH THE SYSTEM FROM THE BATTERY IN MY HIP UP TO THE TIP OF THE LEADS. THE SETTING CHANGED DID NOT HELP AND I EVEN TURNED OFF THE DEVICE AND WAS STILL SHOCKING ME. I CALLED (B)(4) AGAIN AND MET WITH THE REPRESENTATIVE AND AN ENGINEER FROM BOSTON SCIENTIFIC ON (B)(6). THE ENGINEER RESET THE STIMULATION BUT ADVISED THAT THE SHOCKING WOULD NOT STOP. BUT SHOULD DECREASE OVER TIME. HE TOLD ME THIS IS A KNOWN ISSUE. I DO NOT REMEMBER HIS NAME, NOR THE NAME OF THE REPRESENTATIVE WHO WAS THERE. THE SHOCKING, STINGING, BURNING CONTINUES IF I ACCIDENTALLY BEND AND TURN MY HEAD AT THE SAME TIME. THE PAIN FROM THE SHOCK TIGHTENS MY MUSCLES AND EXACERBATES THE VERY PAIN THE STIMULATOR IS SUPPOSED TO ASSUAGE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
334100 SPNIAL CORD STIMULATOR SPINAL CORD STIMULATOR LGW BOSTON SCIENTIFIC SC-1110-12

Patients

Seq Age Sex Outcome Treatment
1 63 YR