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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 Material Integrity Problem (2978)
Patient Problems Pain (1994); Swelling/ Edema (4577)
Event Date 03/01/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8711, serial#: (b)(4), implanted: (b)(6) 2006, product type: catheter. Other relevant device(s) are: product id: 8711, serial/lot #: (b)(4), udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a company representative regarding a patient receiving bupivacaine 20mg /ml at 2. 50mg/day and dilaudid 10mg/ml at 1. 25mgd/ay via an implantable pump. The indication for use was non-malignant pain and other non-malignant pain. It was reported that the patient has had a 2 month history of increased pain and leg swelling. During this time the patient was diagnosed with a fractured catheter. Today the physician did a catheter revision and a new 8598a revision kit was used and spliced to the existing 8711 catheter. Per the reporter, they have to dilute the existing drug in the pump and refill with a lower concentration and states the pump tubing will have the higher concentration and they can't achieve the dose the physician has ordered. It was discussed removing system contents or min rate mode.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14433942
MDR Text Key292035355
Report Number3004209178-2022-06354
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/28/2020
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/18/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/08/2019
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: 05/19/2022 Patient Sequence Number: 1
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