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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 Therapeutic Response, Decreased (2271); Sleep Dysfunction (2517)
Event Date 02/26/2020
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 regarding a patient previously receiving intrathecal fentanyl and unknown morphine (concentrations and doses unknown) via an implanted pump. It was reported the patient¿s pump alarm was continuously going off. The patient¿s pump ran out of mediation and on (b)(6) 2020, the patient¿s pump started alarming every 10 minutes. It was noted, following this, the patient went through withdrawals. Now that the patient had gone through the withdrawals, she felt like she would be better off without the medication in the pump and had no plans to refill the pump. The caller requested assistance silencing the alarm and the alarm was not allowing the patient to sleep. The caller was redirected to the healthcare provider (hcp) to address the alarm. Physician listings were requested, as the patient had ¿fired¿ her hcp and refused to see him. The patient did not currently have medication in their pump but used to have morphine and fentanyl. 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key9998221
MDR Text Key190192360
Report Number3004209178-2020-07694
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 04/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2020
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 Received04/22/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/25/2019
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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