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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 Problem Kinked (1339)
Patient Problems Abdominal Pain (1685); Emotional Changes (1831); Tachycardia (2095); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Chills (2191); Complaint, Ill-Defined (2331); Sleep Dysfunction (2517); Underdose (2542); Cognitive Changes (2551)
Event Date 03/17/2014
Event Type  Injury  
Manufacturer Narrative
Relevant components include: product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2014 explanted: (b)(6) 2015 product type catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the past couple of refills or increases in medication had given the patient ¿horrendous¿ side effects including chills, cold sweats, heart beating fast, nightmares, vomiting, abdominal pain, talking in her sleep, and ¿all kinds of things¿ that the patient did not have before. The patient went to the emergency room 2 nights ago. The patient had a refill on thursday and by saturday she was in the emergency room because she was ¿completely out of her head. ¿ the patient was in tears about her situation. She had been having such a bad experience and was at the point where she wishes she never got it. The patient sometimes felt like she was being underdosed. The patient was taking oral morphine before the pump was implanted. The patient was told to keep taking the oral morphine when the pump was implanted. When the patient told her health care provider (hcp) of her symptoms, the hcp told her to stop taking oral morphine. The symptoms came back with a later refill and the hcp told the patient to take the oral morphine again. The system was being used to deliver morphine. Additional information was received from a consumer (con). It was reported that at this time the patient was critically ill, and was so sick. The patient could not get ahold of her pain doctor at all while in the hospital. The surgeon had to go vacation with his wife and left without checking her. The results found were that a kink was found and ultimately the pump was removed. It was a long time ago and the patient guessed that (b)(6) 2015 was about right. No further complications were expected or anticipated.
 
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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 Key7006405
MDR Text Key91268219
Report Number3004209178-2017-23279
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 11/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2015
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received11/02/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/23/2014
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: 11/07/2017 Patient Sequence Number: 1
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