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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 Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 12/01/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a manufacturer representative (rep) regarding a patient who was receiving fentanyl (500 mcg/ml at 31. 45 mcg/day) via an implantable pump for unknown indications for use. It was reported that the patient had 2 car accidents in (b)(6), 1 week apart from each other. The rep stated that the patient was seen for a refill on (b)(6) 2022 but the interrogation said the reservoir volume was 12 ml, so they did not perform the refill and sent the patient home. The rep stated that today ((b)(6) 2022) was the first refill since the car accident and the programmer said the reservoir volume was 9 ml with low reservoir alarm date on (b)(6) 2022; however, the pump was actually empty. The rep stated that the patient had reported experiencing an increase in pain a couple of days after the car accident. Of note, there were no motor stalls. The rep noted that the patient's dose at max activation was 151. 14 mcg/day. The rep wanted to review programming since they want to fill the pump with saline and bring the patient back early to check for volume discrepancies.
 
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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 Key13712379
MDR Text Key290689351
Report Number3004209178-2022-03044
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Date Manufacturer Received04/15/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/30/2021
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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