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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 Abdominal Pain (1685); Unspecified Infection (1930); Pain (1994); Swelling (2091)
Event Date 05/03/2017
Event Type  Injury  
Manufacturer Narrative
Other relevant components include: product id 8780 lot# serial# (b)(4) implanted: (b)(6) 2016 explanted: (b)(6) 2017 product type catheter. (b)(4). A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via manufacturer representative regarding a patient receiving morphine 2mg/ml for a total dose of 0. 2001mg/day via an implantable pump for non-malignant pain. It was reported the patient had an increase in post implant pain and swelling. The patient had a computed tomography (ct) scan, a catheter dye study, and was seen in the emergency room (er) a couple of times regarding pain in abdominal area. The pump and catheter were explanted on (b)(6) 2017 and will not be returned for analysis. Cultures of pump pocket site were sent to pathology. Surgical intervention occurred as the patient was seen in the er on (b)(6) 2017 for possible pump site infection. The patient was discharged and referred to neurosurgery for a pocket revision. Upon opening the pump pocket site, it was noted that the patient had an active infection and the decision was made to completely explant both the pump and the catheter. It was noted that the issue was resolved at time of report, and the patient's status at time of report was "alive-no injury. " the patient's weight was 103kg. The patient's medical history was asked, but unknown. Event date was (b)(6) 2017. No further complications were reported/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 Key6797206
MDR Text Key82783516
Report Number3004209178-2017-17537
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
Report Date 08/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/14/2018
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 Received06/20/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/15/2016
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: 08/16/2017 Patient Sequence Number: 1
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