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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 Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Unintended Movement (3026)
Patient Problems Pocket Erosion (2013); Skin Erosion (2075); Urinary Retention (2119)
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) regarding a patient receiving intrathecal prialt 4 mcg/ml at 0. 3004 mcg/day, unknown baclofen 100 mcg/ml at 7. 51 mcg/day, and dilaudid 5 mg/ml at 0. 3755 mg/day via an implanted pump for non-malignant pain. It was reported pump erosion occurred (on an unknown date) in the area of the pocket and the device eventually ruptured the skin. The patient was in the hospital for a pocket revision due to the pump coming through subcutaneously. The drug dose had been reduced for that procedure, but now they wanted to reduce the dose again by 25% because the patient was having urinary retention since the revision this last week. The reason for the call was, they were unable to reduce the dose by 25% due to programming limitation. It was reviewed minimum rate mode was an option and reviewed the baclofen dose was already at a dose that would be considered non-therapeutic. It was noted the change in therapy/symptoms was sudden. It was noted there was no allegation against device sterility and treat ment was ongoing. The patient was hospitalized. The rep would check with her physician to see if minimum rate was a better option or if he wanted to run the pump at the lowest simple continuous rate. No further complications were reported/anticipated or expected.
 
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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7742038
MDR Text Key115783512
Report Number3004209178-2018-17125
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,Followup
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/28/2017
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/07/2016
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: 08/02/2018 Patient Sequence Number: 1
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