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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 Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
Patient Problems Fatigue (1849); Nausea (1970); Vomiting (2144); Shaking/Tremors (2515)
Event Date 12/01/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was receiving therapy via an implantable pump for unknown indications for use. It was reported that the patient had a surgical procedure unrelated to pump/therapy performed in november and at the refill in december a volume discrepancy was noted where the patient "had more in the pump than what the machine said". A refill was performed 2 weeks ago and the tablet indicated no issues/alarms, but the healthcare provider (hcp) withdrew 17cc. The caller stated that "i went through withdrawal with that one". The patient was given oral dilaudid. When the hcp checked the pump today they "withdrew 28 and the meter said there should be 32 or something". The caller mentioned that they have been experiencing nausea, vomiting, shaking, episodes where they want to sleep, and stated when these feelings occurred it was very sudden.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13711903
MDR Text Key295357961
Report Number3004209178-2022-03035
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 03/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received03/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/08/2017
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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