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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 Improper or Incorrect Procedure or Method (2017)
Patient Problems Fall (1848); Complaint, Ill-Defined (2331)
Event Date 06/01/2017
Event Type  malfunction  
Event Description
Information was received from a consumer regarding a patient who was receiving fentanyl at an unknown concentration and dose via an implantable pump for spinal pain. It was reported on (b)(6) 2017 that the patient¿s pump was refilled with the wrong medication. It was detailed that the patient was supposed to have only fentanyl put in the pump but they put in fentanyl and clonidine as the clinic grabbed the wrong patient¿s medication and put it in the pump. It was noted that the medication mistake made the patient ¿goofy¿ and the patient feel three times in five days. It was indicated that the dose and concentration were unknown, and that the patient was only supposed to have fentanyl in the pump but at one time clonidine was accidentally put in. The date of the event was (b)(6) 2017. Physician listings were requested. No further complications were reported 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 Key6822717
MDR Text Key83747865
Report Number3004209178-2017-18194
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 08/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2015
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 Received08/23/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/12/2014
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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