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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problems Insufficient Flow or Under Infusion (2182); Application Program Problem (2880)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id 37092, product type accessory. Product id neu_ptm_prog. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was receiving 2500 mcg/ml of fentanyl at 549. 9 mcg/day via an implantable pump for non-malignant pain. On (b)(6) 2020, it was reported that the patient's pump was always locking them out when they tried to deliver a bolus. According to the patient, they would always see a 3 hour lockout. The patient provided their personal therapy management programmer (ptm) lockout parameters as: 1x/3h, 8x/day. It was considered possible that the patient was experiencing uplink interference. The patient's healthcare provider (hcp) reportedly did not know why the lockouts were happening. The patient was sent a ptm antenna. The patient also reported that they did not believe that they were getting all their boluses because there was always drug left in the pump at refills. The patient reported have 10 ccs or more in the pump and the hcp was varying refill dates from 6 to 8 weeks sometimes because there was drug in the pump. The patient noted that they sometimes do not use all of all 8 boluses. No symptoms were reported. No further complications were reported.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
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
7635149628
MDR Report Key10444651
MDR Text Key204524926
Report Number3004209178-2020-14633
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/20/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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