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Model Number 8637-20
Device Problems Vibration (1674); Volume Accuracy Problem (1675); Improper or Incorrect Procedure or Method (2017); Temperature Problem (3022)
Patient Problems Abdominal Pain (1685); Apnea (1720); Bradycardia (1751); Fatigue (1849); High Blood Pressure/ Hypertension (1908); Itching Sensation (1943); Overdose (1988); Burning Sensation (2146); Coma (2417); Loss of consciousness (2418); Low Oxygen Saturation (2477); Sleep Dysfunction (2517); Cognitive Changes (2551); Confusion/ Disorientation (2553); Electric Shock (2554); Loss Of Pulse (2562); Test Result (2695)
Event Date 03/01/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event Description
Additional information was received from the patient. It was reported that when they went to refill the pump they missed the port, the patient went into a coma, and they were in intensive care for 4 days and was overdosed. The patient also mentioned they had their teeth removed due to osteoporosis and are losing so many bone chips that they can¿t have dentures until the bone chips clear up. The patient reported that they were prescribed high powered meds to build up their bones. The patient confirmed this was unrelated to the pump. No further complications were anticipated/reported.  .
Manufacturer Narrative
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 2000 mcg/ml clonidine at a dose of 351 mcg/day, 40 mg/ml bupivacaine at a dose of 7. 019 mg/day, 600 mcg/ml compounded baclofen at a doseof 105. 21 mcg/day, and 8. 2 mg/ml dilaudid at a dose of 1. 439 mg/day via an implantable pump for failed back surgery syndrome and non-malignant pain. It was reported that the patient had overdose symptoms within minutes of the refill. The patient started reporting a burning sensation in the pump pocket after 2 ml had been put into the pump. The hcp stopped the refill and aspirated and was able to aspirate all 2 ml out. The hcp continued with the refill and filled the pump with 19 ml. The patient continued to have the burning sensation around the pump and then started having a diminished level of consciousness and eventually lost consciousness. The patient was brought to the emergency room (er) and started on a narcan drip. The patient appeared stable and they planned on continuing the narcan drip overnight. The patient was very thin and after the patient reported the burning sensation, they double checked the needle placement and they were certain they were in the port. The hcp had not aspirated the pump reservoir to see if they could get all 19 ml back. The patient reported a similar burning-type sensation along with itching around the pump area after giving herself a bolus using the personal therapy manager (ptm), but the details were not specified. It was considered a sudden change in therapy/symptoms.
Manufacturer Narrative
Event Description
Additional information was received from a business partner on 2017-apr-28. The patient was a (b)(6) female. The patient weight was (b)(6). On (b)(6) 2017, it was learned that the patient¿s medical history included severe degenerative thoracolumbar scoliosis (dorsalgia, kyphoscoliosis), multiple lumbar surgeries (extensive lumbar fusion and harrington rods ((b)(6) 2016 fused t12-l4), blood clots, chronic cervical pain, smoker, back pain (dorsalgia, chronic midline thoracic back pain), osteoporosis, kyphosis, a lung nodule, drug allergy to gabapentin (hallucinations), drug allergy to oxycodone (vomiting). On (b)(6) 2016, the patient started receiving compounded baclofen with the reporting provider¿s facility. On (b)(6) 2017, the patient was seen for a pump refill. With second aspiration of the pump, a residual volume of 5. 5 ml was expected and 3. 2 ml was obtained and wasted. Then 1 ml of the new medication was infused at a rate of 1ml/3 second and after 1 ml of the medication was infused, 1 ml of clear fluid was aspirated which confirmed needle placement. At that time, the patient reported some burning at the needle site with infusion of the medication. The infusion was stopped and the needle placement was confirmed by another provider. At that time, 2 ml of medication was slowly infused and the entire 2 ml were aspirated back to again confirm needle placement. The infusion/aspiration process was repeated for a total of 5 mls of medication. Then 10 ml of the medication was infused with aspiration of 2 ml after every 3 ml infusion. The patient reported ongoing burning at the site of the needle as well as itching around the pump. Given the patient¿s response, the provider elected to aspirate as much of the medication back as she could. She obtained 19. 5 ml of the original 20 ml of medication. At that time, the managing physician was asked to verify the needle placement and assess the patient. The patient was experiencing burning at the needle site and itching around her pump but no hives or rash were noted. As they waited for the physician, the patient started ¿acting restless¿ and wanted to scratch around her pump. She became confused and less coherent. She ¿dozed off¿ but would easily arouse to verbal stimuli but then would doze off again. The patient¿s husband was asked if the patient tended to frequently doze off during t he day and this was confirmed. The patient had changed from her baseline from earlier in the appointment as she had been alert, oriented, and providing subjective history. The physician saw the patient and confirmed the needle placement in the it (intrathecal) cen tral compartment. He recommended removing the needle and reassessing the pump while the patient was supine. The patient had become increasing confused and drowsy. While lying on the exam table, she was somnolent and would only arouse briefly to loud verbal stimuli and sternal rub. During that time, the patient¿s respiratory rate was 12 to 17/minute and she had brief periods of apnea. The patient¿s oxygen saturations were 84% to 96% on room air and her heart rate was 58 to 62. The physician assessed the patient¿s lung and heart sounds which were clear and regular. The physician then accessed the patient¿s pump with a new needle and he verified the needle placement. Approximately 0. 3 ml of medication was aspirated out of the pump and was wasted. At that time, the patient¿s pump was refilled under supervision of the physician, with frequent aspiration of 3 to 4 mls back after every 5 mls infused (to verify the needle placement). The patient¿s pump was updated to reveal 19 ml of new medication. Following the pump refill, the physician recommended transporting the patient to the emergency room for further evaluation. As the patient was moved to a gurney, she hollered out ¿no, no, no¿ then fell back asleep. The patient¿s pump log revealed that she had received a bolus dose at 04:00 that morning (along with boluses at 00:47 and 02:39). Per pump logs, the patient had used 5 to 10 boluses/day from (b)(6) 2017. Per clinic/pharmacy records, the patient also had access to morphine 15 mg (filled on (b)(6) 2017) and oxycodone 5 mg (filled on (b)(6) 2016). The last fill date for oral dilaudid 2 mg was (b)(6) 2017. With the pump refill completed, the patient was transported to the hospital and admitted with the emergency room (er) diagnosis of acute unintentional opioid overdose. She underwent a ct scan which revealed no acute changes and er lab work which showed increased levels of alkaline phosphatase and co2. A uds (urine drug screen) was ¿presumptive¿ for oxycodone. With the hospitalization, the patient received a narcan drip for 12 hours and was then weaned from the drip. On (b)(6) 2017, a pump dye study was performed and was negative. The patient was discharged from the hospital on (b)(6) 2017. As of (b)(6) 2017, use of the product was ongoing. It was stated that the patient had an elevated blood pressure reading and right lower quadrant abdominal pain. No additional information was provided. Concomitant products included cymbalta (duloxetine hydrochloride) at 30 mg, 1x day; topiramate at 100 mg, 2x/day; lasix (furosemide) at 20 mg, reported as every 48 hours and 1x/day; dilaudid (hydromorphone) at 2 mg, 1 to 2 tablets every 8 hours as needed; duloxetine delayed release at 30 mg, one capsule 1x/day; klor-con (potassium chloride) at 10 meq, 1 tablet 1x/day; and robaxin (methocarbamol) at 500-1000 mg, every 6 hours as needed. There were no further complications reported or anticipated.
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event Description
Additional information was received from a consumer on (b)(6) 2017. The patient stated that 2. 5 to 3 months ago (as of (b)(6) 2017), the patient went to fill the pump and they overdosed her. The patient stated she ¿literally died and they brought her back 2-3 times¿. The patient was in the intensive care unit (icu) for 3. 5 days. The patient stated that ever since then, she had been experiencing times where the patient would be sitting, standing, or laying in bed and all of a sudden she would ¿feel like she was vibrated like she was being electrocuted¿. The patient stated it would ¿blast for a few moments and then slowly stop, but it was throughout her whole body¿. The patient was due to see her pump managing healthcare provider (hcp) on (b)(6) 2017 or so. The patient stated that she had 4 medications in the pump, but didn¿t know the name of all of them and didn¿t know the dose and concentration.
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event Description
Additional information was received from a healthcare provider (hcp) on 2017-jul-06. The patient was seen at the clinic on (b)(6) 2017, but did not make her hcps aware of any symptoms of vibration or electrocution-like feelings. The hcp was not aware of any further device or therapy issues regarding the patient.
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Manufacturer (Section D)
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key6393293
MDR Text Key102393161
Report Number3004209178-2017-05350
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 consumer,health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date02/28/2014
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received01/16/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/30/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1060-2011

Patient Treatment Data
Date Received: 03/09/2017 Patient Sequence Number: 1