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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Muscle Weakness (1967); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Sedation (2368)
Event Date 07/27/2019
Event Type  Injury  
Manufacturer Narrative
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 company representative regarding a patient receiving baclofen (2000 mcg/ml at 220 mcg/day) via an implanted pump. The indication for pump use was intractable spasticity. On (b)(6) 2019 it was reported that 24 days after the patient¿s pump was replaced on (b)(6) 2019 the patient started having withdrawal symptoms. The patient got itchy and started having return of spasticity. The patient had to be hospitalized for a while (dates unknown by reporter). The physician did a cap (catheter access port) aspiration successfully and it was noted that the catheter was not touched during the pump replacement procedure. The physician changed the daily dose from 220 mcg/day to 400 mcg/day and was giving the patient oral medication and that seemed to control the situation. The physician saw the patient yesterday ((b)(6) 2019) for a refill and right after he filled the pump, the patient went super loose like an overdose. The physician reduced the dose to 220 and monitored the patient. The physician confirmed the drug concentration with the surgeon. The patient¿s change in therapy/symptoms was a sudden change. No further complications have been reported as a result of this event.
 
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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 Key9155880
MDR Text Key162976117
Report Number3004209178-2019-18992
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 10/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/14/2020
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 Received10/08/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/23/2019
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: 10/04/2019 Patient Sequence Number: 1
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