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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 Insufficient Flow or Under Infusion (2182); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2014, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 01-oct-2016, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer via a manufacturer representative regarding a patient who was receiving baclofen via an imp lantable pump for non-malignant pain and lumbar radiculopathy. It was reported that 20 ml was aspirated from the pump when only 2 ml were expected. A catheter dye study is scheduled for tomorrow. There were no external factors that contributed to the event. The event was not resolved at the time of the report.
 
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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 Key14408254
MDR Text Key291837491
Report Number3004209178-2022-06242
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,Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/16/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Date Manufacturer Received05/16/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/25/2019
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: 05/16/2022 Patient Sequence Number: 1
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