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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 8637-40
Device Problems Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Application Program Problem (2880)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2020
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 8835, product type: programmer. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was receiving 10 mg/ml of morphine at 7. 004 mg/day via an implantable pump for spinal pain. On (b)(6) 2020, it was reported that the patient's pump began alarming on (b)(6) 2020 because they missed their refill date. According to the patient, the alarm first started as a single-tone alarm sound on (b)(6)2020 and then changed to a dual-tone alarm that sounded like an ambulance on (b)(6) 2020. The pump was refilled and the alarm was resolved, but the patient's personal therapy management programmer (ptm) refill date did not updated when they had the pump refill. The refill date was still showing as their previous refill date. According to the patient, their next refill date was still showing as (b)(6) 2020 and their last refill date was showing as (b)(6) 2020. The patient reported that their most recent pump refill was done by the pharmacy ("ais") that was sent to the patient's home. The patient was not able to go to their clinic due to covid restrictions. The patient noted that their medication and dose/concentration had not changed and inquired about how to get the refill date updated. No symptoms were reported. No further complications were reported.
 
Manufacturer Narrative
Product id: 8835, serial# (b)(4), product type: programmer, patient. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer. The serial number of the ptm was reported. It was reported that the issue of the ptm displaying the wrong refill date was resolved after the patient talked to the hcp.
 
Manufacturer Narrative
Product id: 8835, product type: programmer, patient. If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2020-july-14, additional information was received from the patient that reported they were just at their hcp's office and the rep updated the refill date on their ptm.
 
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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 Key10264145
MDR Text Key198526506
Report Number3004209178-2020-12030
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,Followup,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/28/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/05/2014
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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