SPINAL PAK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-18 for SPINAL PAK manufactured by Biomet.

Event Text Entries

[5229934] Skin reaction to the electrical pads. Growth of a tumor where the pad was used. Tumor wrapped around my carotid artery and may have caused vertigo and ringing in my ear. I needed surgery to remove the tumor, which may grow back. After cervical infusion for c-4 thru c7, i was given a spinal pak by biomet. This is a bone growth stimulator. After just one day of wearing this device, i began to have a skin reaction under the pads due to the "sticky" backing. I ordered a 3m product called cavilon, which protects the skin for those who must use medical products on a long term basis, e. G. Colostomy tubes. It allowed me to wear the bone growth stimulator for 24 hours, seven days a week for four months. A few weeks after i stopped wearing the device i began having an increase in my lymph count on my blood count results. I also began having dizzy spells (vertigo) and ringing in the ears as well as vision problems. I saw a neurologist who thought i had myasthenia gravis. I also went to the eye doctor who found that i had double and blurred vision and agreed with my seeing the neurologist. We tried two prescriptions and i had a brain ct and mri to rule out a thymoma or other ear or brain problems. My lymph count continued to rise. My rheumatologist finally told me to have my lymph node biopsied. When my surgeon opened my neck to remove the node, he found a warthin's tumor wrapped around my carotid artery and attached to the salivary gland on the right side of my neck/jaw. These tumors are usually found in males who smoker or chew tobacco. I have never done either one. Presently i am waiting to see a doctor at (b)(6) medical center in (b)(6). I am starting to think i may have another tumor on the left side of my neck where the other pad was placed. If so, i will need another surgery. Meantime the fusion i had on my cervical spine seems to have failed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5039212
MDR Report Key4270877
Date Received2014-11-18
Date of Report2014-11-10
Date of Event2014-08-28
Date Added to Maude2014-11-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSPINAL PAK
Generic NameSPINAL PAK
Product CodeLOE
Date Received2014-11-18
OperatorLAY USER/PATIENT
Device Sequence No1
Device Event Key0
ManufacturerBIOMET


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit 2014-11-18

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