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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 Filling Problem (1233); Insufficient Flow or Under Infusion (2182); Device Ingredient or Reagent Problem (2910)
Patient Problems Fatigue (1849); Dizziness (2194); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/01/2021
Event Type  Injury  
Event Description
Information was received from a healthcare provider (hcp) regarding a patient who was receiving morphine (5 mg/ml at. 4964 mg/day), bupivacaine (5 mg/ml at. 4964 mg/day), and clonidine (400 mcg/ml at 39. 72 mcg/day) via an implantable pump for unknown indications for use. It was reported that in (b)(6) 2021 the patient had a refill and there were residual fluid and also some bubbles. The hcp stated that at the end of the aspiration there was a small amount of yellowish fluid.  the hcp stated that the pump was then refilled, hours later the patient was seen again because they were concerned about getting overdosed. The hcp reported that they aspirated the pump and there was no volume discrepancy. The hcp stated that the patient had 2 refills following this with no issues. At the patient's last refill on (b)(6) 2022 they noted a small amount of yellow fluid again with no volume discrepancy and filled the pump. 8 hours post refill, the patient overdosed and felt dizzy, uncoordinated, dry mouth, and a little sleepy. The hcp stated that the symptoms subsided with no treatment. Of note, the patient had gained weight so it is a little difficult to access.
 
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14243215
MDR Text Key290378087
Report Number3004209178-2022-05415
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 Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/21/2018
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: 04/28/2022 Patient Sequence Number: 1
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