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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 Excess Flow or Over-Infusion (1311); Migration or Expulsion of Device (1395)
Patient Problems Hemorrhage/Bleeding (1888); Renal Failure (2041); Sepsis (2067); Urinary Tract Infection (2120); Loss of consciousness (2418); Decreased Respiratory Rate (2485); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/17/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780 , serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2022, product type catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 29-jan-2022, 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 (hcp) via a company representative regarding a patient receiving dilaudid (10 mg/ml at 7 mg/day) via an implanted pump. It was reported that the patient had a pump refill done at 8:30 a. M. On (b)(6) 2022. The patient returned to the office at 10:30 unresponsive and his breathing was suppressed. An ambulance was called, narcan was administered, the patient became conscious, and the medical staff took him to the closest hospital for evaluation and monitoring. There were no expressed environmental, external, or patient factors that may have led or contributed to the issue. The patient returned to the office the following week for a reservoir aspiration to compare the actual versus the expected volumes. The reservoir was found to be short by approximately 7 ml. The drug aspirated was then placed back into the reservoir and a pump replacement surgery was scheduled. During the procedure, the pump pocket was opened and contained the entire catheter with the pump inside the pocket. None of the catheter was in the spine. The pump pocket was also dry per the hcp. He had expected to see some fluid if the catheter tip was in the pocket, so he was concerned of a pump malfunction. The pump and catheter were replaced, and the issue was noted to be resolved. It was noted that while in the hospital, post pump and catheter replacement, the patient had kidney failure, uti (urinary tract infection), sepsis, and stomach bleeding. The patient was moved to the icu (intensive care unit) and was recovering. His new pump was currently set to minimum rate.
 
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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 Key13633222
MDR Text Key290060143
Report Number3004209178-2022-02624
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 05/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2021
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/02/2020
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: 03/01/2022 Patient Sequence Number: 1
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