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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Sepsis (2067)
Event Date 10/23/2019
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 (hcp) on 2019-nov-13 regarding a patient receiving unknown baclofen (dose and concentration unknown) via an implanted infusion pump. The indications for use included intractable spasticity and cerebral palsy. It was reported that the patient had sepsis and was in the intensive care unit at the time of report. The sepsis was reportedly gone, but the patient also had a low blood pressure episode. It was noted that the patient was experiencing refractory hypertension and the hcp was looking for someone to help adjust the dose. It was believed that the baclofen pump was contributing to the patient's condition. The pump was last refilled around three weeks ago (relative to the date of report). 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 Key9336628
MDR Text Key166979948
Report Number3004209178-2019-22035
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
Type of Report Initial
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/28/2020
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received11/13/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/09/2019
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: 11/18/2019 Patient Sequence Number: 1
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