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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 Infusion or Flow Problem (2964); No Flow (2991)
Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Irritability (2421)
Event Type  Injury  
Manufacturer Narrative
Concomitant product(s): product id: 8709, serial# (b)(4), implanted: (b)(6) 2003, explanted: (b)(6) 2018, product type: catheter. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 31-mar-2005, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2018-july-13, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving baclofen (2,000 mcg/ml, 400 mcg/day) via an implantable pump for intractable spasticity and cerebral palsy. Beginning on an unknown date, the patient experienced baclofen withdrawal and "increased spasticity irritability". There were no known environmental, external, or patient factors that may have led or contributed to the issue. The reported troubleshooting stated, "catheter access done with no flow observed". The catheter was replaced on (b)(6) 2018. The event was resolved at the time of this report. The patient's status was alive - no injury.
 
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 Key7690529
MDR Text Key114070679
Report Number3004209178-2018-15820
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 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2016
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/16/2015
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: 07/16/2018 Patient Sequence Number: 1
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