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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 Problems Migration or Expulsion of Device (1395); Difficult to Advance (2920)
Patient Problem Complaint, Ill-Defined (2331)
Event Date 11/27/2017
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 consumer on 2018-aug-21 regarding a patient receiving unknown medication (dose and concentration unknown) via an implanted infusion pump. It was noted that the patient was not sure of the medication, but thought it was morphine and bupivacaine. The indication for use was non-malignant pain. It was reported that the pump was floating around again and she could feel it spinning around on the inside and it was flip-flopping. It was noted that people could see it sticking out because it was not laying flat on its side. The reported issues occurred "about 3-4 weeks after implant," on (b)(6) 2017. It was noted that the pump was emergency removed on (b)(6) 2018 by an unknown healthcare provider (hcp). The change in therapy/symptoms was considered gradual. No further complications were reported or anticipated.
 
Manufacturer Narrative
Correction/update: the previously reported information is related to manufacturer report # 3004209178-2018-19088. B5 has been updated with the correct information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp). The cause of the pump floating, and flipping was no anchor sutures. Patient weight was (b)(6) pounds. The pump was explanted.
 
Manufacturer Narrative
Product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: catheter, udi# (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare professional (hcp). The patient had the pump inserted by outside physician and it was non-function. The pump was revised, and the catheter was not intrathecal. Attempts to place the catheter were unsuccessful due to having fusion. The catheter was cut. The plan was to have spine surgery revise. Unable to find a surgeon willing to do this therefore the patient was brought back to operating room (or) and the pump was removed. At the time of removal the pump was not anchored. It was unknown if this was not done originally or if the sutures were not patent. The cause of the issue was not determined. The pump was explanted and removed catheter that was installed. Patient weight was (b)(6).
 
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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 Key7812556
MDR Text Key118109883
Report Number3004209178-2018-19092
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 consumer,health professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 09/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/24/2017
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: 08/24/2018 Patient Sequence Number: 1
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