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Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Itching Sensation (1943); Muscle Spasm(s) (1966); Muscular Rigidity (1968); Overdose (1988); Tachycardia (2095); Therapeutic Effects, Unexpected (2099); Twitching (2172); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Sedation (2368); Loss of consciousness (2418); Shaking/Tremors (2515); Sleep Dysfunction (2517); Cognitive Changes (2551)
Event Date 12/23/2017
Event Type  Injury  
Manufacturer Narrative
Device code (b)(4) does not apply. If information is provided in the future, a supplemental report will be issued.
Event Description
Additional information was received from a healthcare provider on 2018-feb-23 and a business partner on 2018 (b)(6). It was reported that additional medical history included a gastroscopy; insertion of vp (ventriculo-peritoneal) shunt; laser eye surgery (left eye as a child); bilateral dislocations of the hip joint; muscle release procedure to allow hips back into place; and incision and drainage of hematoma (seroma or fluid collection). Concomitant medications included baclofen 20 mg at 20 mg 2x/day orally, zithromax (azithromycin), tamiflu (oseltamivir) 75 mg, and protonix (pantoprazole) 40 mg at 40 mg 1x/day. On an unspecified date in 2004, the patient started treatment with lioresal (baclofen) at an unknown concentration and dose, per continuous infusion, intrathecally. Indications for use included cerebral palsy and spasticity. After the pump change on 2017 (b)(6) and addition of medication, the patient presented with symptoms of sedation, increased blood pressure (bp), tachycardia, fever, confusion, and leg jerking. It was further noted that on 2017 (b)(6), the patient was seen in rehabilitation clinic for a pump interrogation. It appeared the pump was working well and the patient's family seemed reasonably pleased with how he was doing, but requested a "slight bump" in his dosing. The healthcare provider reportedly recommended 10%, but the family only wanted to give him a 5% increase. At that time, the patient's dosing was 806. 47 mcg/day and was increased to a total of 847. 6mcg/day. On 2018 (b)(6), the patient was seen in outpatient clinic for a pump check and evaluation. The family reported that the patient was just not himself and was less talkative as he liked to talk a lot. The patient was having more spasms and was also somewhat sedated with a decreased level of alertness. The patient's withdrawal symptoms were clarified by the patient's mother as "spasticity and loose. " a review of symptoms was performed and urinary incontinence was noted. A physical examination was performed and revealed the patient was a little more sleepy than usual and had a slight increase in tone in the lower extremities ("with tone in the solids 2 out of 4 range"), particularly in the hamstrings. The patient also had knee flexion contractures bilaterally. With that appointment, the pump was checked and the tubing appeared to be patent. The patient was to have 0. 196cc in the catheter tubing and a physician was able to pull out about 10cc of cerebrospinal fluid (csf). During the testing, there was a question as to if the patient had received a possible bad batch of baclofen. The pump was interrogated, which revealed the patient was receiving baclofen 2000mcg/ml at 807. 6mcg/day via simple continuous mode. The intrathecal baclofen was removed and about 9. 2cc was pulled out and sent for analysis. The patient's pump was refilled to see if that would help and no changes were made to the patient's dosing. A specimen of the concentration of what was remaining in the pump was sent for evaluation. With that 2018 (b)(6) visit, a culture and wbc (white blood count) were performed with no results provided. The patient's pump was refilled and the dosing was left so it could be determined if the previous old baclofen (removed from the pump)had something to do with his symptoms. The patient's family was asked to call the hcp the following day to let them know how the patient was doing. On 2018 (b)(6), the patient was seen in the emergency room and reported sleep and pain to an emergency room physician. On 2018 (b)(6), the patient's parents called the clinic with concerns as the patient was more spastic, hadn't slept for 19 hours, and was unable to be awakened after the 5% increase. The family was reportedly concerned that something was going on with the pump. It was further clarified that both times they had problems, the pump was checked out by a manufacturer representative and checked out okay. It was clarified that there were no issues with the pump and that it was due to the drug in the pump. It was confirmed that the connector tubing was replaced, but per the hcp, it was replaced as a precaution. The catheter number was unknown, but the model number was noted to be 8709. The pump serial number was provided. Additional information was received from a healthcare provider on 2018 (b)(6). It was clarified that the catheter itself was not replaced, just the tubing to the catheter.
Manufacturer Narrative
The main component of the device system; the other relevant components include: product id: neu_unknown_cath, serial# unknown, product type: catheter. If information is provided in the future, a supplemental report will be issued.
Event Description
Information was received from drug partners regarding a patient receiving lioresal with an unknown concentration for a total dose of 847. 6mcg/day via an implantable pump for no known indication for use. It was reported on (b)(6) 2018, additional information was received from a hcp. Medical history included cerebral palsy, spasticity (muscle spasticity), and implantations of an unspecified intrathecal pump and catheter in 2008 (model numbers not provided, implant date noted as "on pump for over 10 years"), and an unspecified intrathecal pump (model number not provided, implanted on (b)(6) 2017 as old pump battery was nearing end-of-life). Concomitant products were not reported. On an unspecified date, the patient started treatment with lioresal at an unspecified concentration and dose, intrathecally via the unspecified pump, for an unreported indication. On (b)(6) 2017 at a clinic visit, the patient's dose was increased to lioresal (concentration not specified) at 847. 6 mcg/day. On (b)(6) 2017, after starting the product, the patient was "readmitted" (hospitalized) with jerking, shaking, and insomnia. The connector tubing was replaced and the patient "did better. " on (b)(6) 2018, the patient was brought to a clinic with concerns of withdrawal symptoms, which was clarified as the patient had increased spasticity, was more spastic (with spasms), itching, and was posturing. The patient had a lack of therapeutic effect with lioresal. At the clinic visit the patient was noted to have not slept for 19 hours. On an unspecified date, the patient experienced overdose symptoms. On (b)(6) 2018, the patient could not be wakened. During a clinic visit on the same day, the patient was less talkative, had a bp (blood pressure) of 176/97, and a hr (heart rate) of 115. The tubing and pump were evaluated ("fluoroed/fluoroscopy") to make sure the tubing was not kinked, and were found to be functioning as intended. The medication was withdrawn from the pump and replaced with new medication. The patient had not experienced any recent illnesses. No additional information was provided. The event involved or prolonged inpatient hospitalization. The patient's weight was unknown. The date of onset was (b)(6) 2017. No further complications were reported/anticipated.
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Manufacturer (Section D)
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer (Section G)
800 53rd ave ne
minneapolis MN 55421 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key7251834
MDR Text Key102864477
Report Number3007566237-2018-00395
Device Sequence Number1
Product Code LKK
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,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNEU_UNKNOWN_PUMP
Device Catalogue NumberNEU_UNKNOWN_PUMP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/23/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/08/2018 Patient Sequence Number: 1