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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 Fluid Leak (1250); Obstruction of Flow (2423)
Patient Problems Edema (1820); Pain (1994); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Date 10/17/2019
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 27-jun-2021, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving dilaudid and clonidine at unknown concentrations and doses via an implantable infusion pump. It was reported that the patient's pump was implanted on (b)(6) 2019 and hadn't been helping since then. He was in a lot of pain and couldn't sleep, could hardly walk and had edema in his legs. The medication had been increased with no effect. Two dye studies were completed in (b)(6) 2020 and the patient stated that "they think it could be a kinked catheter or something" and "they said something about it leaking in the epidural area" of his spine. He was going to get a chest x-ray at some point. He expressed frustration that he couldn't find out the results of the dye studies and didn't know what was going on. The patient was redirected to continue working with his doctor. 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 Key9933426
MDR Text Key186714261
Report Number3004209178-2020-06820
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 consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/07/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/06/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/26/2019
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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