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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 8637-40
Device Problems Kinked (1339); Unstable (1667); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)
Patient Problem Therapeutic Effects, Unexpected (2099)
Event Date 02/01/2018
Event Type  Injury  
Manufacturer Narrative
References the main component of the device system the relevant components include: product id: 8781, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a manufacturer's representative (rep) regarding a patient receiving 16 mg/ml morphine at a dose of 0. 99 mg/day via an implantable infusion pump for spinal pain. It was reported that the patient had a lack of therapy. The hcp reported pulling out 38 cc at last refill in (b)(6) 2018. The pump said 3 cc in pump and the hcp pulled out 38. An environmental/external/patient factors that may have led or contributed to the issue was that the patient's pump flipped. A catheter and dye study was performed on (b)(6) 2018. The hcp was unable to aspirate from the access port as well as push dye. As an action/intervention taken to resolve the issue, the patient was sent to the surgeon for catheter replacement. The issue was not resolved at the time of this report. Surgical intervention was planned, after diagnostic catheter and dye study it was suspected that the catheter was kinked. The hcp was to be sending a referral to a surgeon for a revision. The patient's status was "alive - no injury" and no further complications were expected or 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 Key7303820
MDR Text Key101237566
Report Number3004209178-2018-04195
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
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received02/27/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/21/2017
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: 02/28/2018 Patient Sequence Number: 1
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