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Model Number 8637-40
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Fatigue (1849); Granuloma (1876); Incontinence (1928); Neuropathy (1983); Pain (1994); Increased Sensitivity (2065); Ambulation Difficulties (2544); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
The main component of the system and other applicable components are: product id: 8709, serial# (b)(4), implanted: (b)(6) 2005, product type: catheter. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Event Description
Information was received from a healthcare provider (hcp) regarding a patient who was receiving an unknown drug at an unknown concentration and dose via an implantable pump for post lumbar laminectomy syndrome and spinal pain. It was reported that the patient was having an mri due to a problem with the device or therapy. The mri was to check the tip of the catheter for suspected granuloma. The patient also had increased low back pain. The hcp had no further information about the event.
Event Description
Additional information was received from a healthcare provider (hcp) on 2017-mar-16. The patient had an appointment on (b)(6) 2017. The patient presented for follow-up and stated she was having increasing difficulty with bowel/bladder incontinent (not able to feel if she needs to go). The patient had been wearing depends and stated this had been going on for greater than 4 months. The patient stated her balance was off and has had near falls with the most recent incident occurring 2 months ago. The patient had a tooth extraction 2 weeks ago and was given post op vicodin 5/325. The patient stated that ¿i¿m done. I am just so exhausted. ¿ the patient did not elaborate on this statement. The patient¿s pain was at a 10+. The chief complaint was lumbar spinal pain. The patient was a (b)(6) white female coming in for a reevaluation of her low back pain. The patient continued to report pain in the central aspect of the low back. The patient had increased low back and lower extremity pain for the last 4 months. They described the lower extremity pain left greater than the right through the anterior aspect of the thigh to the knee. The pain would occasionally radiate on the lateral aspect of the thighs. The patient had several falls last summer. The last 4 months she had incontinence of the bladder with total loss of control of her bladder with no feeling that she had lost control. The patient had no urge to urinate. The patient reported she normally moves her bowels every other week, but over the last several months she moves her bowels every 3 weeks after taking a laxative. The patient had no feeling when she moves her bowels and no urge to move her bowels. The patient scored a 4/5 muscles testing throughout the lower extremities bilaterally. The patellar reflexes were plus one bilaterally and ankle reflexes were trace bilaterally. The impression was stated as lumbar spinal pain with features of discogenic syndrome and facci arthropathy with history of lumbar rhizotomies. There was a possible granuloma/obstruction and intrathecal catheter tip resulting in the symptoms. There was lower extremity radiculopathy. The patient had osteoarthritis and obesity. There was bilateral ulnar neuropathy and carpal tunnel syndrome with right ulnar release in (b)(6) 2016. There was possible hyperalgesia. The plan was to do a lumbar mri with and with out contrast to evaluate increased low back pain, incontinence and intrathecal catheter tip for granuloma/obstruction. The plan also included bun (blood urea nitrogen)/creatinine prior to the mri. The patient was advised to take the laxatives so she moves her bowels weekly. The patient would be referred for neurosurgical evaluation for low back pain, incontinence, lack of feeling with bowel movements, lack of urge to move bowels, and increased pain. The intrathecal morphine pump was increased minimally with boluses at 0600 and 1800 increased from 3. 798 milligrams each to 3. 807 mg each. The total daily dose increased from 12. 881 mg/day to 12. 899 mg/day. The patient would follow-up on prior to low reservoir alarm of (b)(6) 2017. The hcp agreed on decreasing the concentration of morphine 30 mg/ml for the next refill. The current medications the patient was receiving were as follows: benadryl as needed, byetta 10 mcg pen (250 mcg/ml one a day), garlic (1000 mg, 2 orally per day), keflex (250 mg twice a day), klonopin (1 mg, one per day), lasix (40 mg, one per day), morphine (30 mg/ml for pump, 41 ml total), potassium (99 mg as needed), synthroid ( 75 mcg, one per day), temazepam (15 mg, one per day). The medication allergies were as follows: anti-depressants, compazine (extreme violent), relan, bupivacaine hcl (nausea, vomiting, diarrhea, numbness, dizziness, blurred vision, personality change), prinivil. The past health history included arthritis, degenerative bone disease, diabetes, thyroid dysfunction, and problems with anesthesia (meanness). The surgeries and hospitalizations were listed as: 3 lumbar surgeries, hysterectomy, gastric bending, gallbladder, neck surgery, morphine pump implant, and vertebroplasty. The patient had 6 mva¿s (motor vehicle accidents). It was stated that an x-ray was performed that revealed the right baby toe was broken. The patient¿s blood pressure was 105/71 mmhg and radial pulse was 88 beats per minute. The patient¿s height was (b)(6) and weight was (b)(6). The patient¿s bmi (body mass index) was (b)(6).
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Manufacturer (Section D)
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa clark
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key6339312
MDR Text Key101651719
Report Number3004209178-2017-04075
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 03/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1151-2008

Patient Treatment Data
Date Received: 02/17/2017 Patient Sequence Number: 1