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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 Hematoma (1884); Rash (2033); Complaint, Ill-Defined (2331)
Event Date 06/13/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received via manufacturer representative from a patient who was receiving an unknown drug at an unknown concentration and dose via intrathecal drug delivery pump for non-malignant pain. It was reported that the patient had a consistent rash on the skin around his pump area. There were no environmental/external/patient factors that may have led or contributed to the issue. The patient saw a dermatologist. A pocket revision was performed to reduce pushing on the skin. The issue was not resolved at the time of this report and the patient status was "alive - no injury. " no further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a health care provider on (b)(60 2018. It was reported that the cause of the rash was not determined, but it was noted by the dermatologist he saw that it was likely not a hypersensitivity to the pump materials themselves, and he also noted he didn't think it was a reaction to the medications as they hadn't changed. The patient was seen recently at the clinic to discuss further treatment options and the nurse noted the pump site looked much better, and the redness had reduced. She said the rash was considered resolved. They gave the patient several options, including an evacuation of a potential hematoma. The nurse noted the pump was "still protruding slightly. " the patient's weight at the time of the event was unknown. No further complications were reported.
 
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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 Key7607155
MDR Text Key111262849
Report Number3004209178-2018-13579
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,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2018
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received06/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/12/2017
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: 06/15/2018 Patient Sequence Number: 1
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