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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 Difficult to Insert (1316); Migration or Expulsion of Device (1395); Aspiration Issue (2883); Device Operates Differently Than Expected (2913); Difficult to Advance (2920)
Patient Problem Arachnoiditis, Spinal (2390)
Event Date 12/21/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2017, product type: catheter. Product id: 8780, serial# (b)(4), product type: catheter.
 
Event Description
Information was received from a healthcare professional via a company representative regarding a patient receiving fentanyl (4,000 mcg/ml at 192. 1 mcg/day) and clonidine (200 mcg/ml at 9. 61 mcg/day) via an implanted pump. The indication for pump use was non-malignant pain. On (b)(6) 2016 the patient had a catheter dye study and the radiologist was unable to aspirate. The patient¿s managing physician had been treating the patient with oral medication. The patient had not had withdrawal symptoms. On (b)(6) 2017 the patient was taken to surgery and in surgery the surgeon attempted to aspirate the catheter and he was unable to. He felt that the catheter may be out of the intrathecal space, so he attempted to insert a new catheter but was unable to. The surgeon felt that maybe the patient had arachnoiditis, but also there was so much bone he had trouble getting into the intrathecal space. The surgeon chose not to proceed. The existing pump and catheter were removed. The issue was resolved. The patient status was reported as ¿alive ¿ no injury¿. It was unknown if any environmental, external, or patient factors led or contributed to the inability to aspirate.
 
Manufacturer Narrative
Device code (b)(4) is no longer applicable for this event.
 
Event Description
Additional information was received and it was reported that the difficulty encountered during the surgery when trying to implant the new catheter was that the surgeon could not get the needle into an open space; it wasn¿t an issue with the catheter.
 
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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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6303854
MDR Text Key100589781
Report Number3004209178-2017-02609
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,Followup
Report Date 02/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2015
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 Received02/07/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/03/2014
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: 02/06/2017 Patient Sequence Number: 1
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