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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 Difficult to Advance (2920); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/27/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2021, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 24-sep-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving fentanyl (300 mcg/ml at 55. 0 mcg/day) via an implantable pump. It was reported that during a catheter placement on (b)(6) 2021, the physician had difficulty getting the catheter into the intrathecal space. The physician used a long spinal needle. Once the physician got the catheter in the intrathecal space, there was little to no spinal fluid flowing. Ultimately, there were intermittent minimal drips. A dye study was done that appeared to be successful. The catheter was then connected to the pump and again got little to no drips of spinal fluid. A second dye study was attempted that appeared to be successful. The physician then updated the pump for the patient to start getting medication. The issue was reported to be resolved at the time of report. The patient's weight and medical history were asked and will not be made available. The patient's status at the time of report was alive - no injury.
 
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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 Key13159975
MDR Text Key286358605
Report Number3004209178-2022-00091
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 01/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received01/04/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/21/2021
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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