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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 Excess Flow or Over-Infusion (1311)
Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Insufficient Information (4580)
Event Date 04/19/2022
Event Type  Injury  
Manufacturer Narrative
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 and a consumer regarding a patient receiving fentanyl, bupivacaine, and clonidine via an implanted pump. The indication for pump use was spinal pain. It was reported that two home health agency nurses completed a pump refill on (b)(6) 2022. Two hours later, the patient started to feel sleepy; had low blood pressure; went to the er (emergency room); got narcan; and threw up. No pocket fill occurred as the nurses checked multiple times as they filled the pump. A home health nurse went to the er and reported that 5 ml was missing from the reservoir. The drug was aspirated from the reservoir and the pump was refilled with saline and a bridge bolus was performed. No issues showed in the pump logs. There were no environmental, external, or patient factors that may have led or contributed to the issue. A dye study was being considered, but there were no plans at this time. The issue was not resolved at the time of the report, and it was indicated that the hcp had no further information to provide regarding the event. Additional information was received from the patient on (b)(6) 2022 who reported that she had been having troubles since tuesday ((b)(6) 2022) and was currently in the icu (intensive care unit) at the hospital. She stated that she had reached out to her pump hcp but hadn¿t heard back yet.
 
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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 Key14216815
MDR Text Key290140710
Report Number3004209178-2022-05285
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
Type of Report Initial
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2021
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/08/2020
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: 04/27/2022 Patient Sequence Number: 1
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