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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 Failure To Service (1563); Device Displays Incorrect Message (2591)
Patient Problems Diarrhea (1811); Pain (1994); Vomiting (2144); Therapeutic Response, Decreased (2271); Malaise (2359); Sleep Dysfunction (2517)
Event Date 03/19/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer on 2018-apr-30. It was reported that the patient was still not able to find a doctor to refill her pump since her last call. Everyone she called either wasn't accepting new patients or did not have the right drugs to fill her pump. She stated her pump was "completely empty now and she is in full withdrawal" for the past three days relative to 2018-apr-30. She was in pain, throwing up, having diarrhea and wasn't able to sleep. The patient was redirected to seek medical attention. 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 Key7476227
MDR Text Key107236447
Report Number3004209178-2018-09720
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
Report Date 05/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2017
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 Received04/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/04/2016
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: 05/01/2018 Patient Sequence Number: 1
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