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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); Insufficient Information (3190)
Patient Problems Dyspnea (1816); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)
Event Date 11/20/2021
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 consumer via a manufacturer representative regarding a patient who was receiving morphine (unknown dose and concentration) and baclofen (unknown) via an implantable pump for intractable spasticity. It was reported that the pump has been alarming for 2. 5 days and patient doesn't know the reason. Patient stated they recently had pump filled on 12-nov. Patient stated they are currently on their way to hcp to have pump checked. Patient mentioned "last time" patient's pump alarmed "it was terrible, it beeped that it was empty and patient couldn't breathe at all because their muscles were getting hard". Patient was redirected to hcp to assess further.
 
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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 Key12922268
MDR Text Key281650427
Report Number3004209178-2021-17933
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,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received12/29/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/09/2014
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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