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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 Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)
Patient Problems Dyspnea (1816); Nausea (1970); Therapeutic Response, Decreased (2271); Malaise (2359)
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2018, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving morphine (unknown dose and concentration) via an implantable pump for spinal pain. The rep called in to report they were contacted by the hcp and notified that the patient had been reporting since (b)(6) 2017 that they had been feeling as though they were not getting efficacy anymore. The rep stated that the patient felt flu-like symptoms but the patient did have the flu twice between (b)(6) 2017 and present time so that made it confusing for the hcp to diagnose the issue. The rep reported that the patient was refilled in (b)(6) 2018 and a volume discrepancy was identified (arv less than erv). The actual reservoir volume (arv) was 0 ml, and the expected reservoir volume (erv) was 3. 7 ml. The pump was refilled and after the refill, the patient reported feeling nauseous and shortness of breath for about 48 hours. The rep was not aware of any difficulties with refilling the pump. The rep was encouraged to evaluate for other possible causes. The rep stated that the hcp was scheduling diagnostics for the system and stated that the hcp mentioned a dye study and rotor study. The rep stated that the hcp would text the rep once the appointment was scheduled. Additional information provided stated that the hcp reported that the patient was "kooky". The rep stated that the patient was fine at the last refill and had no issues or questions, but when the patient came into the office today ((b)(6) 2018), they were angry and demanding to know why the pump was empty.
 
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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 Key7651881
MDR Text Key112859362
Report Number3004209178-2018-14705
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 company representative,health
Reporter Occupation
Remedial Action Notification
Type of Report Initial
Report Date 06/29/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2017
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/11/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1570-2014

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