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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 Migration or Expulsion of Device (1395); Unexpected Therapeutic Results (1631); Patient-Device Incompatibility (2682); Unintended Movement (3026)
Patient Problems Diarrhea (1811); Fever (1858); Pain (1994); Increased Sensitivity (2065); Swelling (2091); Therapeutic Effects, Unexpected (2099); Chills (2191); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)
Event Date 05/17/2018
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 receiving dilaudid, dose and concentration not reported via an implantable pump. The indication for use was non-malignant pain. On (b)(6) 2018 it was reported that the patient thought they were having a reaction to their pump replacement. The patient stated that this pump hasn't worked to help the pain like the last one, however the patient does get some relief with the pump. The patient was having severe pain and gets these episode like she was going through withdrawal. Per the patient the withdrawal symptoms would subside and then a month would go by and they would come back again. The patient experienced heightened sense of smell and taste, body chills, couldn't eat since saturday, fever, shakes, and loose stools. The patient stated that their healthcare provider refilled their pump on a friday and was changing the patient over from morphine to a different drug. The patient stated that she does have a lot of left over medication in the pump when she gets her refills but stated it¿s never been mentioned that it is a concern. The patient¿s healthcare provider has never done any tests on the pump either to look into the issue. Per the patient their pump was not alarming at that time. The patient had spoken to their healthcare provider about this and per the patient the healthcare provider stated he had never heard of this before. The patient was not hearing the pump alarming but one time when the patient bent over she did feel the pump flip. The patient tried to push it back in and now the patient feels their pump has moved down and there is swelling in their abdomen. The patient planned to follow up with their healthcare provider. No further complications were reported regarding the event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key7698467
MDR Text Key114678305
Report Number3004209178-2018-16039
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
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/02/2017
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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