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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 Filling Problem (1233); Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2019
Event Type  malfunction  
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) regarding a patient who was receiving 575mcg/ml compounded baclofen at 50mcg/day and saline via an implantable infusion pump for spinal pain. It was reported that at a refill the hcp was unable to aspirate from the pump. The patient recently had the pump implanted and they were trying to remove the saline and put in the baclofen. The patient had 6. 9ml in the pump and it took many tries to remove it. They filled 10ml of baclofen in the pump but couldn¿t remove any of it. They were going to try a locked valve procedure. No symptoms were reported. No further complications were anticipated/reported.
 
Manufacturer Narrative
Updated to reflect the information received on 2019-apr-17. (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on 2019-apr-17 from the healthcare provider (hcp). It was reported that the hcp was still struggling to fill the pump. They were able to aspirate 9. 1cc which was expected. They tried to fill the pump and could only get 1-2 cc. They were going to use a 30 cc syringe and do a negative pressure procedure. The hcp used a 60 ml syringe and held negative pressure for 10 minutes and the pump would still not unlock. They then pushed 5 ml of saline in the pump with a 5 ml syringe and repeated that 3 times, unlocking the valve. 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 Key8516845
MDR Text Key142076691
Report Number3004209178-2019-07457
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2020
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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