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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Overdose (1988); Decreased Respiratory Rate (2485)
Event Date 05/08/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a manufacture representative regarding a patient that was receiving morphine (2. 1 mg/ml at 0. 1 mg/day) via an implanted pump. The indication for use was non-malignant pain and failed back surgery syndrome. It was reported the patient presented to the emergency department with respiratory depression and low blood pressure on (b)(6) 2019. The pump dose had been change that day to. 1mg/day after 2 catheter aspirations and 2 catheter primes was performed. It was unknown if the patient was taking any oral medications that may have contributed to the patient's symptoms. The pump was interrogated and reduced the dose to minimum rate,. 0126 mg /day. The patient had been admitted to the hospital and administered narcan. It was noted the issue resolved. The patient was still in the hospital and was stable. There may have been other health issues associated to why the patient remains in the hospital.
 
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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 Key8607448
MDR Text Key144952652
Report Number3004209178-2019-09557
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 05/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/14/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/21/2018
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: 05/14/2019 Patient Sequence Number: 1
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