FDA Adverse Event Injury Summary report: N

MEDTRONIC SYNCROMED II IMPLANTABLE INFUSION PUMP

MDR report key: 1141631 · Received August 28, 2008

Report

Report Number
MW5008114
Event Type
Injury
Date Received
August 28, 2008
Date of Event
June 18, 2008
Report Date
August 28, 2008
Manufacturer
MEDTRONIC NEUROMODULATION PATIENT SERVICES
Product Code
MEB
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN 2008, I HAD A MEDTRONIC SYNCHROMED II INTRATHECAL INFUSION PUMP INSERTED BY A DR. WITHIN ONE WEEK, I DEVELOPED SEVERE HEADACHES, NECK PAIN AND A 3' X 4' SEROMA OVER THE LUMBAR SURGICAL SITE -APPROX. THE SIZE OF A SOFTBALL CUT IN HALF- AND A 6' X 8' SEROMA OVER THE ABDOMINAL SITE, WHICH WAS VERY PAINFUL TO TOUCH, WARM TO TOUCH, REDDENED AND SWOLLEN. I IMMEDIATELY CONTACTED DR WHO AFTER EXAMINING THE SEROMAS, ADVISED THAT HE DID NOT FEEL THAT THERE WAS AN INFECTION. HE WITHDREW 20 CC'S OF FLUID FROM THE ABDOMINAL SEROMA AND 40CC FROM THE LUMBAR SEROMA. AFTER WITHDRAWING THE FLUID, HE THEN THREW THE SAMPLES INTO THE TRASH WITHOUT SENDING THEM FOR ANALYSIS. WITHIN 24 HOURS, THE SEROMAS RETURNED AND I DEVELOPED SEVERE DIPLOPIA OF THE RIGHT EYE. DR AGAIN SAID THAT HE DIDN'T FEEL THAT THIS HAD ANYTHING TO DO WITH THE PUMP, BUT REFERRED ME TO AN OPHTHALMOLOGIST. ON AN EMERGENCY BASIS. AFTER MULTIPLE TESTS AND AN MRI OF THE BRAIN, DR(SECOND) REFERRED ME TO NEURO-OPHTHALMOLOGIST AT THE UNIVERSITY, WHO SUGGESTED THAT THE 6TH CRANIAL NERVE WAS INVOLVED, AND THAT IT COULD BE RELATED TO AN INCREASE OR DECREASE IN INTRACRANIAL PRESSURE, AND ORDERED AN IMMEDIATE LUMBAR PUNCTURE. DURING THE LUMBAR PUNCTURE, THE INTERVENTIONAL RADIOLOGIST ASKED ME IF I HAD BEEN EXPERIENCING HEADACHES, WHICH I ADMITTED THAT I HAD AND ALSO HAD MADE FIRST DR AWARE OF. THE RADIOLOGIST THEN STATED THAT I HAD VERY LOW INTRACRANIAL PRESSURE. IT WAS ALSO RECOMMENDED TO ME BY THE HOSPITAL, THAT I SEE AN INFECTIOUS DISEASE SPECIALIST. I WAS SEEN BY ANOTHER DR. IN 2008. DR(THIRD) IMMEDIATELY INDICATED THAT THE SWELLING WERE NOT SEROMA'S BUT AN INFECTION. HE IMMEDIATELY ORDERED CULTURES OF THE ABDOMINAL AND LUMBAR SITES. HE ATTEMPTED TO CONTACT DR(FIRST), BUT WAS UNABLE TO SPEAK WITH HIM, NOR DID HE RECEIVE A CALL BACK ANY TIME FOLLOWING. I AGAIN SAW THE DR(THIRD) ON TWENTY FIVE DAYS LATER, WHO ADVISED THAT THE CULTURE RESULTS HAD COME BACK POSITIVE FOR MRSA OF THE PUMP SITE. DR(THIRD) INDICATED THE MEDTRONIC PUMP SHOULD BE REMOVED AS SOON AS POSSIBLE IN ORDER TO REDUCE THE POSSIBILITY OF THE INFECTION SPREADING TO THE CEREBRAL SPINAL FLUID OR BLOODSTREAM. WHEN THE I.D. ASKED ME IF I HAD HEARD FROM DR(FIRST) REGARDING THE CULTURES, I REPLIED NO. DR(THIRD) WAS OBVIOUSLY DISTURBED BY THIS AS DR(FIRST) HAD RECEIVED THE LAB RESULTS TWO WEEKS BEFORE HIM, BUT FAILED TO CONTACT ME WITH THE RESULTS. DR(THIRD) IMMEDIATELY CALLED DR(FIRST) AND ADVISED OF THE CULTURE RESULTS AND ADVISED THAT THE MEDTRONIC PUMP NEEDED TO BE REMOVED ASAP. THE PUMP WAS REMOVED ON THE FOLLOWING DAY AT THE SURGERY CENTER. NOW THAT THE PUMP HAS BEEN REMOVED, I PLAN ON IMMEDIATELY SWITCHING PAIN MANAGEMENT PHYSICIANS AFTER I SEE DR(FIRST) TOMORROW FOR MY MONTHLY MEDICATION VISIT, AS IT IS MY OPINION THAT DR(FIRST) ACTED NEGLIGENTLY BY INITIALLY THROWING OUT THE FLUIDS ASPIRATED FROM TO SURGICAL SITES IN APPROX THREE MONTHS EARLIER. FAILING TO NOTIFY ME OF THE IDENTIFICATION OF MRSA IN THE INFUSION PUMP SITE AND FOR FAILING TO RETURN ANY OF MY CALLS OR THIRD DR'S CALLS. THE PUMP HAS BEEN REMOVED AND RETURNED TO MEDTRONIC FOR FURTHER ANALYSIS. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CHRONIC SPINAL PAIN RESULTING FROM AN MVA IN 2005. S/P GASTRIC BYPASS SURGERY IN 2003 WHICH AFFECTS ABSORPTION. DOSE OR AMOUNT: 1.74 MG. FREQUENCY: CONTINOUS. ROUTE: I T.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTRONIC SYNCROMED II IMPLANTABLE INFUSION PUMP CALIBRATION CONSTANT 120 MEB MEDTRONIC NEUROMODULATION PATIENT SERVICES 8637-20

Patients

Seq Age Sex Outcome Treatment
1 41 YR Other| S