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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 Problem Insufficient Flow or Under Infusion (2182)
Patient Problems Pain (1994); Sleep Dysfunction (2517); Insufficient Information (4580)
Event Date 03/01/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiv ing an unknown drug via an implantable pump for spinal pain. It was reported that the patient had been extremely difficult to work with and all the healthcare provider's (hcp) had fired them from their practice. The patient's pump had gone empty for a week or more (the company representative (rep) had been given different dates so they couldn't confirm when it occurred). Last night the patient went to the emergency room (er) in desperation to have their pump refilled. The rep was thinking about turning off the pump alarm since the patient noted they had not been able to sleep due to it alarming and had been very adamant about it being turned off. Rep wanted to know steps on how to turn off pump alarm if it was empty. Technical services reviewed steps on how to do so by programming a false volume in order to update pump and putting a note to document there was no volume in reservoir. The rep was not with the patient. The patient later called in to report that their hcp "suddenly without cause kicked me out of their practice". Their pump went empty and started alarming causing them to go through withdrawal and to be "living in hell since february 10th", and states they have increased pain and are "going crazy. " they couldn't find a doctor in their area that could take them sooner than a month from now. Patient services offered hcp list but the patient declined stating they called all those hcp's. Patient services reviewed mdt vs hcp role. The patient was extremely escalated and emotional during call and stated they couldn't live like this. Patient services offered to bridge the patient with crisis center but they stated they didn't need to talk to someone about this they just needed someone to turn the pump off. The patient spoke with a rep who "said they had connections" of an hcp who could fill pump, but then stated "it wasn't true, they blatantly lied to me and gave me false hope". Patient services again reviewed mdt vs hcp role.
 
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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 Key14014500
MDR Text Key289431318
Report Number3004209178-2022-04267
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2017
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/28/2015
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: 04/05/2022 Patient Sequence Number: 1
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