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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 Occlusion Within Device (1423); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883)
Patient Problem Therapeutic Response, Decreased (2271)
Event Type  Injury  
Manufacturer Narrative
Continuation of medical devices: product id 8709sc, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2018, product type catheter. Information references the main component of the system. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 30-oct-2009, udi#:(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving gablofen (500 mcg/ml, 100 mcg/day) via intrathecal drug delivery pump for intractable spasticity and spinal cord injury/spinal cord disease. It was reported that the patient had an abrupt onset of loss of therapy and despite dosing increases the symptoms persisted. "1 week ago" the hcp attempted a dye study and was unable to aspirate from the catheter access port. "today" they did a catheter replacement. The pump was refilled in the operating room "today" and the expected residual volume was 17. 5 ml while the actual residual volume was 35 ml. The catheter was occluded. The rep required assistance related to programming a priming bolus. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional. It was reported that it was unknown whether the catheter would be returned to the manufacturer for analysis. The patient's symptoms were resolved. The patient's weight at the time of the event was unknown. No further complications were reported.
 
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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 Key7504687
MDR Text Key107956693
Report Number3004209178-2018-10640
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
Report Date 05/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2016
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 Received05/15/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/26/2014
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: 05/10/2018 Patient Sequence Number: 1
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