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Model Number 8637-40
Device Problems Filling Problem (1233); Unstable (1667); Volume Accuracy Problem (1675); Communication or Transmission Problem (2896)
Patient Problems Pain (1994); Discomfort (2330); Complaint, Ill-Defined (2331)
Event Date 01/01/2017
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 8835, serial/lot #: (b)(4), (b)(6), (b)(4) if information is provided in the future, a supplemental report will be issued.
Event Description
Information was reported by a consumer regarding an implanted pump system which was used to deliver fentanyl. The indication for use was non-malignant pain and chronic low back pain. On (b)(6) 2017 it was reported that the physician had a little trouble with finding the port the last few times the patient had a refill, which was reported as since (b)(6) 2017. It was reported that the physician had to ¿dig around¿ to find the port. It was noted that the patient had spoken to a company representative/nurse regarding this issue and repositioning the pump in (b)(6) 2017 but the pump had 22 months left. See (b)(6) ptm wont work. Additional information was received from a consumer on 2017-sep-06. It was reported that they had to move the patient¿s pump because the patient had lost 66 lbs and the pump moved. It was noted that some of the patient¿s healthcare professionals (hcp) ¿monkey with [the pump]¿ causing it to flip but the patient did not do that and the pump was not flipped, per the consumer. It was also noted that the hcp had a little difficulty refilling the pump, which had been going on for ¿probably four months. ¿ it was related that the patient had spoken with manufacturer's representative as the patient¿s had trouble getting the personal therapy manager (ptm) to work and that the manufacturer's representative told the patient how to lay to get the ptm to work and it had helped. It was stated that they were trying to get as much life out of the pump as possible since it was implanted in 2013. Further information was received from a consumer on (b)(6) 2017. It was reported that the patient¿s pump was starting to hurt and poke out. It was stated that it wasn¿t hurting when the patient called before on (b)(6) 2017 and it started 4-5 days ago (note this is conflicting with the report that it wasn¿t hurting on (b)(6) 2017, which was only 2 days prior to this report). It was noted that the patient didn¿t want to have surgery yet as the patient wanted to wait until the ¿five year mark on the battery. ¿ additional information was received from a consumer. The patient was receiving morphine and fentanyl at unknown doses and concentrations. The patient had lost a significant amount of weight and had told the doctor it was starting to hurt because where the pump was at was putting pressure on her ribs. When the pump was implanted, the patient weighed (b)(6) and now weighed (b)(6) and had lost "about 75" pounds. It was noted the patient's weight loss occurred since last (b)(6). Additionally, the patient reported that she was having trouble with the ptm and it "doesn't want to work" and was "driving her nuts". The patient would request a bolus "over and over again" but it would only give the descending tones. The patient would try doing a back bend, which was painful in and of itself, to try and give herself a bolus, but was unsuccessful. It was stated the patient had been back bending, moving around, and "everything she can think of" to try to get the bolus to go through successfully. It was noted after the descending tones, her ptm's light "beeps" and she would see a man next to a pump picture, a pump picture with a cross, and a roll of tape and an x. It was noted the patient had been having trouble with the ptm for "probably 3 months" and she had just been "fiddling with it". When the patient attempted to give herself a bolus with the antenna, she saw the poor communication screen. After detaching the antenna, it was confirmed the bolus was successful. No further issues were reported or anticipated. Additional information was received from a consumer indicated that the patient had a history of celiac disease and had loss a large amount of weight ((b)(6)) causing the pump to bulge out of her body and cause pain. It was noted that the last 3-4 times ((b)(6) 2018 and the 3 previous months) that the pump had been read the amount of medication left in the pump was different than the amount that was expected so the healthcare provider (hcp) was concerned that there might be a kink in the catheter due to the patient's weight loss. It was reported that the hcp performed a "scan" to figure out if just the pump needed to replaced or if the catheter was not functioning properly as well. The caller was directed to follow up with the hcp. No further complications have been reported as a result of this event.
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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 Key7491989
MDR Text Key107753365
Report Number3004209178-2018-10293
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
Reporter Occupation
Type of Report Initial
Report Date 05/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2014
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received05/03/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/10/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial