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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 Electromagnetic Interference (1194); Excess Flow or Over-Infusion (1311); Insufficient Flow or Under Infusion (2182)
Patient Problems Arrhythmia (1721); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received by a consumer (con) and company representative (rep) regarding a patient who was receiving bupivacaine (5. 0 mg/ml at 0. 7091 mg/day) and dilaudid (hydromorphone) (6. 0 mg/ml at 0. 8510 mg/day) via implantable infusion pump. It was reported that for the past 2 years the patient has been experiencing over and under dosing from the pump. The patient stated that this occurs after refills and adjustments. The patient mentioned that at 11:50pm, 1am, and 2am they get mini doses from the pump causing symptoms like they cannot breathe. Of note, the patient never drops below 80% saturation. The patient also stated that sometimes the opposite happens, and the pump does not give them the medication and then medication all at the same time. The patient stated that it has not been confirmed that the pump is doing this, but the patient read about recalls online and believes the pump is doing this. The patient wants the healthcare provider (hcp) to look at the pump or take the pump out. The patient underwent an mri on (b)(6) 2021 to see if there was an inflammatory mass at the tip of the patient's catheter. Th mri did not end up scanning the location of the catheter tip so an inflammatory mass could not be determined. The pump did however stall at the time of the mri scan at 9:30am and recovered 30 minutes later. The remainder of the pump log did not show any abnormalities. The patient thought their pump alarmed on (b)(6) 2021; however, it was confirmed that the pump log did not show pump alarms occurring. The hcp decided to drop the patient's concentration of hydromorphone from 6 mg/ml to 0. 8 mg/ml and brought the dose from 0. 85 mg/day to 0. 55 mg/day with plans to further decrease the dose to 0. 45 mg/day. Additionally, the hcp disabled the patient's ptm dosing because the patient had reported that the pump systems were exacerbated after ptm use. The hcp provided the patient with oral hydromorphone for breakthrough pain. The patient's relevant medical history included 37 surgeries, been taken off blood pressure medication, and a crash cart was called a year ago february at a refill. The patient additionally mentioned feeling little surges of medication going through and that their heart races and blood pressure skyrockets. The patient also mentioned no longer getting a numbing feel ing since the bupivacaine has been removed but is getting an analgesic "nerve block" feeling from the chest down.
 
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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 Key12085018
MDR Text Key265584556
Report Number3004209178-2021-10110
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,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/19/2017
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: 06/29/2021 Patient Sequence Number: 1
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