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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 Misconnection (1399); Suction Problem (2170); Connection Problem (2900); Gas Leak (2946); Infusion or Flow Problem (2964); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2018
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are product id: 8780 , serial# (b)(4), implanted: (b)(6) 2018, product type: catheter; (b)(6), (b)(4); product id: 8784, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter; (b)(6), (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a manufacturing representative (rep) regarding a patient being implanted with a new pump for spinal pain. The pump was filled with saline. It was reported when the doctor was implanting a new pump and catheter on (b)(6) 2018 they encountered difficulty when connecting the catheter to the pin connector/collet. The surgeon had a difficult time placing the collet and connecting the pin connector to the catheter. The rep stated that the collet locked before the surgeon could slide the catheter in, so they opened-up an ascenda revision kit and the collet locked again before it could be connected to the catheter. The surgeon then opened an anchor removal tool kit and got the catheter connected to the pin connector using the collet. The rep reported when the surgeon tried to aspirate from the catheter access port (cap) after connecting everything there was not a free flow of cerebrospinal fluid (csf) and there was some difficulty aspirating, and some bubbles. The rep reported the surgeon had free flow earlier during the procedure. No symptoms were reported. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturing representative (rep). It was reported the problem was not with the collet, it was a use issue. It was indicated the managing physician will plan a dye study to confirm why it was difficult to aspirate cere brospinal fluid (csf) from the catheter access port (cap). The patient's weight was not recorded, and was therefore unavailable.
 
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 Key7687393
MDR Text Key114155394
Report Number3004209178-2018-15752
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2019
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/18/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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