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Model Number 8637-40
Device Problems No Audible Alarm (1019); Excess Flow or Over-Infusion (1311); Premature Elective Replacement Indicator (1483); Insufficient Flow or Under Infusion (2182); Failure to Disconnect (2541); Communication or Transmission Problem (2896); Inappropriate or Unexpected Reset (2959); Data Problem (3196)
Patient Problems Bruise/Contusion (1754); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)
Event Date 07/14/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8835, serial# :unknown, product type: programmer. If information is provided in the future, a supplemental report will be issued.
Event Description
Information was received from a consumer and healthcare provider (hcp) via a company representative regarding a patient with an implantable pump for non-malignant pain. The pump administered fentanyl (concentration: 2000 mcg/ml, dose rate: 1110 mcg/day (max 1360. 4) and bupivacaine (concentration: 18. 9 mg/ml, dose rate 9. 5 mg/day). It was reported that during the day ((b)(6) 2020) the patient was successful with using their personal therapy manager and received her boluses. The patient gets 17 a day and already done quite a few, but then suddenly the ptm showed a screen that meant telemetry unsuccessful. It was further noted that the patient has a lot of pain from their multiple sclerosis and does a lot of falling. The patient had reported that they had fallen at least twice and that they fall all the time. It was also noted that the patient experiences withdrawal and tweaking if they couldn¿t get a bolus. The patient changed the batteries just before reporting. At the time of the report they worked with the patient to position the ptm and press the selector key, move away from electromagnetic interference (emi), and try again. It was further noted to remove the batteries, and the battery compartment looked good, the batteries being used were duracell coppertop. They worked with patient to try to unstick the keys. The patient attempted a bolus again and got a code (but she did not take note) and then were getting telemetry unsuccessful screen again. A request was made to replace the ptm rega rding the keys / down arrow on the navigator keypad sticking; however, the serial number for the current ptm was not collected at the time of the report. An attempt was made to call the reporter back and a voicemail was encountered. A message was made for the patient to call patient and technical services back with the ptm serial number. It was further noted that the patient had 2 other ptms, one was the new samsung platform ptm and the other was the model 8835 ptm. The patient had chosen to use the ptm from her prior pump (model 8835). The patient had later called back and indicated the code they were seeing via the ptm was an 8310 code which was reviewed as a pump time setup error. The patient was redirected to their hcp. A company representative had later reported that the patient was seeing an 8310 code (err_pump_time_setup) via their personal therapy manager (ptm). The patient was advised to go to the clinic, and the clinic had called the company representative for troubleshooting. The company representative was not at the clinic but conferenced in the hcp. The hcp stated upon interrogating the pump, that there were many pop-up messages and the logs read the following: (b)(6) 2020 at 1:53 pm critical alarm - pump reset, (b)(6) 2020 at 1:53 pm (2b) critical alarm - pump reset due to low battery , and (b)(6) 2020 at 1:53 pm critical alarm - pump defaulted to minimum rate. The pump was previously refilled on (b)(6) 2020, and they filled it to 40 cc and the report displayed that elective replacement indicator (eri) would occur in 69 months. The pump should now have 22. 3 ml in the reservoir but reads 0 ml and the eri displays (less than 1 month - july). The low reservoir date was set to go off on (b)(6) 2020 initially. The hcp confirmed that there were no other logs displayed (no 88 codes, nothing reading "programming step", etc. ) and just the three they had listed off as the only things in the logs. The hcp indicated that the patient's tab was not cleared, the catheter tab was not cleared, the reservoir was cleared to 0 ml, and the infusion mode was reset to minimum rate. The hcp was able to successfully update the pump and read the logs which read "programming step" but in the middle read "critical alarm - pump defaulted to minimum rate" then read "event cleared" with the same timestamp. The hcp then re-interrogated the pump to check if the pump's infusion was reset to minimum rate. The hcp confirmed the infusion read 1,110 mcg/day. The hcp then reported that the pump alarms were not going off and no one in the clinic could hear the alarm. At the time of the report technical services attempted to have caller play the alarm for the patient, but the pump was not making any sound. Technical services reviewed with hcp that this pump would need to be replaced as soon as medically possible. It was noted that the patient had not experienced any falls (contradictory with initially reported information from the consumer), there was no trauma to the pump, and the patient had not had magnetic resonance imaging. On (b)(6) 2020 additional information was received from a healthcare professional (hcp) via a clinical study regarding the patient. It was indicated that there was a pump malfunction of an undetermined etiology. It was noted that the patient tried to use their bolus and was unable to. It was noted the pump was read and showed elective replacement indicator (eri) was 0 and the reservoir had 0ml. It was noted it should have read eri 69 months and reservoir should have been 23ml. It was noted the patient had not fallen on their pump. It was noted they attempted to re-sync the pump and were unsuccessful. It was noted the patient was experiencing withdrawal symptoms due to pump malfunction. The pump was explanted/replaced on an unknown/unspecified date. The outcome of the event was noted as ongoing. The device diagnosis was pump reservoir volume discrepancy and the clinical diagnosis was withdrawal symptoms. The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was unlikely related. The pump was noted as having administered fentanyl (1010. 15711 mcg/day) and bupivacaine (9. 54598 mg/day). The patient¿s weight was provided. No further patien t complications have been reported as a result of this event.
Manufacturer Narrative
Product id: 8835, serial# unknown, product type: programmer, patient; product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2013, product type: catheter. If information is provided in the future, a supplemental report will be issued.
Event Description
Additional information was received from an hcp via a manufacturer representative and a clinical study on (b)(6) 2020. It was reported that the pump was explanted on (b)(6) 2020 and the patient had no withdrawal symptoms on that date. The cause of the reported issues was not reported. It was further clarified that the patient fell routinely due to their unsteady gait from the multiple sclerosis and had some bruising around the pump, but the pump was working with no alerts when it was interrogated on (b)(6) 2020. When they disconnected the sutureless connector, it was difficult to remove so they had to use a new connector. The event resolved without sequelae on (b)(6) 2020.
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
MDR Report Key10284806
MDR Text Key199222504
Report Number3004209178-2020-12341
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 company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/16/2019
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: 07/16/2020 Patient Sequence Number: 1