FDA Adverse Event Injury Summary report: N

PRECISION SPECTRA SPINAL CORD STIMULATOR SYSTEM

MDR report key: 4163252 · Received October 7, 2014

Report

Report Number
MW5038549
Event Type
Injury
Date Received
October 7, 2014
Manufacturer
BOSTON SCIENTIFIC
Product Code
LGW
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

CARL STIMULATOR IMPLANTED IN MY BACK WITH LEADS TO MY CERVICAL SPINE TO ADDRESS CHRONIC PAIN. ON (B)(6) I SAW MY DOCTOR TO HAVE IT ADJUSTED. AFTER LEAVING THE OFFICE I WAS FOUND IN MY STILL-RUNNING CAR SLUMPED OVER THE STEERING WHEEL. PARAMEDICS WERE CALLED AND I WAS UNRESPONSIVE WHEN THEY ARRIVED. I WAS REVIVED AFTER 5 MINUTES OF CPR. I WAS TAKEN TO A NEARBY HOSPITAL WHERE IT WAS REPORTED THAT I WAS HAVING SEIZURES. I WAS TRANSFERRED TO ICU. WHEN THEY LEARNED OF MY STIMULATOR. THEY CALLED MY DOCTOR TO HAVE SOMEONE COME TO TURN IT OFF. MY SEIZURE ACTIVITY STOPPED IMMEDIATELY. I WAS PLACED IN A COMA AND REMAINED IN THE HOSPITAL FOR ABOUT 15 DAYS IN ICU AND STEP-DOWN ICU. FOLLOWING MANY TESTS, THE NEUROLOGIST, TWO CARDIOLOGISTS, AND THE PULMONOLOGIST ALL BELIEVED THAT THE STIMULATOR WAS PLACED TOO CLOSE TO MY HEART AND INTERFERED WITH THE HEART'S ELECTRICAL SYSTEM, CAUSING THE HEART TO STOP. NO OTHER CAUSE COULD BE FOUND AND THERE WAS NO EVIDENCE OF HEART DAMAGE FOLLOWING THE INCIDENT. WHEN A REPRESENTATIVE FROM BOSTON SCIENTIFIC CAME TO DOWNLOAD THE DATA FROM MY DEVICE HE EXCLAIMED, "OH MY GOD! IT WAS UP TO 100 PERCENT!" I LATER LEARNED THAT NO LIMITS WERE SET ON THE DEVICE, ALTHOUGH IT IS CAPABLE OF HAVING LIMITS SET ON IT. DESPITE MY MEDICATION LIST, BLOOD TESTS INDICATED I HAD LESS MEDICATION IN MY SYSTEM THAN SHOULD BE EXPECTED. I TAKE AS LITTLE AS I CAN TOLERATE. STRENGTH: MY SETTINGS MAXED AT ABOUT 28. QUANTITY: SEVERAL PROGRAMS WERE CREATED FOR ME TO CHOOSE FROM. FREQUENCY: USED ALL DAY EXCEPT WHEN DRIVING. HOW WAS IT TAKEN OR USED: IMPLANT OPERATED BY A REMOTE. DID THE PERSON STOP AFTER THE PERSON REDUCED THE DOSE OR STOPPED TAKING OR USING THE PRODUCT: YES. DID THE PROBLEM RETURN IF THE PERSON STARTED TAKING OR USING THE PRODUCT AGAIN: DIDN'T RESTART; THE NEUROLOGIST RECOMMENDED I NOT TURN IT BACK ON. WHY WAS THE PERSON USING THE PRODUCT: IT WAS INTENDED TO REDUCE THE CHRONIC PAIN I WAS EXPERIENCING. DO YOU STILL HAVE THE PRODUCT IN CASE WE NEED TO EVALUATE IT: YES. IT IS IMPLANTED IN ME!

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
629896 PRECISION SPECTRA SPINAL CORD STIMULATOR SYSTEM PRECISION SPECTRA SPINAL CORD STIMULATOR SYSTEM LGW BOSTON SCIENTIFIC SC-6412-3 16483485

Patients

Seq Age Sex Outcome Treatment
1 52 YR Hospitalization| L| R| S NORCO| SUCRALFATE| VITAMIN B-12| OXYCONTIN/OXYCODENE| LYRICA| IRON| PANTOPRAZOLE| VITAMIN D| FLECTOR PATCH| LIPITOR| CYMBALTA| VALIUM