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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 Cyanosis (1798); Dyspnea (1816); Fatigue (1849)
Event Date 05/05/2021
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 health care professional (hcp) via a device manufacturer representative regarding a patient receiving dilaudid (8000 mcg/ml at 3000 mcg/day) via an implantable infusion pump. It was reported that the patient came in for a refill on (b)(6) 2021. Later that day, they experienced drowsiness, labored breathing and cyanotic skin color. They were admitted to the intensive care unit (icu) and given narcan. They withdrew the medication from the pump and got 18mls, but expected 20mls. The doctor suspected overdose and subsequently decreased the infusion rate on (b)(6) 2021. The patient's pain control was not adequate after reducing the infusion rate, so he was prescribed oral supplemental opioids on (b)(6) 2021. The hcp made the decision to replace the pump due to suspected overinfusion. Upon explant, 6. 5mls were expected but the actual residual volume was 3. 5mls. The backflow of cerebrospinal fluid was sluggish. A back table prime was conducted on the new pump prior to attaching to the existing catheter, and infusion was started at 2550 mcg/day without priming the catheter. The issue was considered resolved. The patient's status at the time of the report was alive - no injury. No further complications were reported.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11791399
MDR Text Key249507221
Report Number3004209178-2021-07384
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/28/2020
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2018
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: 05/07/2021 Patient Sequence Number: 1
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