FDA Adverse Event Death Summary report: N

MEDTRONIC ACTIVA DEEP BRAIN STIMULATOR

MDR report key: 3222056 · Received July 2, 2013

Report

Report Number
3222056
Event Type
Death
Date Received
July 2, 2013
Date of Event
June 29, 2013
Report Date
July 2, 2013
Manufacturer
MEDTRONIC
Product Code
MHY
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
TX, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

ON (B)(6) 2013, THE NEUROSCIENCES CLINIC RECEIVED A CALL FROM A MOTHER OF (B)(6), INFORMING THEM THAT HE HAD PASSED AWAY ON (B)(6) 2013, AT HOME, IN THE CARE OF HOSPICE. THIS YOUNG MAN HAD A COMPLICATED MEDICAL HISTORY AND LENGTHY LIST OF PAST SURGERIES, PROCEDURES, AND MEDICATIONS. HE WAS RECENTLY PLACED ON HOSPICE AT THE REQUEST OF HIS MOTHER DUE TO ONGOING CHRONIC PAIN AND DECLINING OVERALL MEDICAL HEALTH. DBS WAS SURGICALLY IMPLANTED ON (B)(6) 2009 AND REMAINED IMPLANTED. MOTHER CALLED ON (B)(6) 2013, REPORTING "HIS HEALTH IS DECLINING." REPORTS A LOT OF PAIN, ABDOMEN IS DISTENDED, TUBE FEEDING HAS BEEN STOPPED. PER MOM HOSPICE DOCTOR IS ADJUSTING PAIN MEDICATIONS TO MAKE (B)(6) MORE COMFORTABLE. PARENTS TURNED OFF DBS ON (B)(6) 2013 AND REPORTED HE WAS ABLE TO RELAX AND GO TO SLEEP. THIS YOUNG MAN WAS BORN AT 30-WEEKS SECONDARY TO PLACENTA PREVIA. HE HAD PERINATAL DEPRESSION/ASPHYXIA AND 3 WEEK NICU STAY WITH EXTENSIVE HYPOXIC ISCHEMIC INJURY. HE HAS STATIC ENCEPHALOPATHY, DEVELOPMENTAL DELAY, AND TORSION DYSTONIA WITH A DBS AND IT BACLOFEN PUMP. SINCE (B)(6) (2012), HAS HAD INCREASING COMPLAINTS OF PAIN, AFFECTING EVERY PART OF HIS LIFE. HE RECEIVES A COMBINATION OF MEDICATIONS IN AN ATTEMPT TO CONTROL HIS PAIN. MOM FEELS THAT A LOT OF PAIN IS DUE TO GI ISSUES AND GAS PAIN. HE IS G-TUBE DEPENDENT. THE DBS SEEMS TO HELP THE DYSTONIA AND PAIN ASSOCIATED WITH CONTRACTURES. ON (B)(6) 2013: SUGGESTED (B)(6)START SEEING A COUNSELLOR. HAS MUSIC THERAPY AT HOME FOR MUSIC THERAPY. RECENTLY STARTED METHADONE. SEEMS TO BE HELPING THE PAIN. ON (B)(6) 2013: DOING OKAY. PAIN NOT AS BAD AS IT WAS. MOM FEELS IT IS MANAGED WELL. SOMETIMES PT IS SLEEPY BUT MOM FEELS METHADONE DOSE IS APPROPRIATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
300426 MEDTRONIC ACTIVA DEEP BRAIN STIMULATOR DBS MHY MEDTRONIC MEDTRONIC RC V259112

Patients

Seq Age Sex Outcome Treatment
1 22 YR Death DIAZEPAM| NEURONTIN| TIZANIDINE| METHADONE| METHYLIN| LIDOCAINE TOPICAL| FLUOXETINE| CARBAMAZEPINE| TRAMADOL| NEXIUM| CLONAZEPAM| METACLOPRAMIDE| ONDANSETRON| BACLOFEN| EES GRANULES