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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 Device Alarm System (1012); Pumping Stopped (1503); Insufficient Information (3190)
Patient Problems Dyspnea (1816); Pain (1994); Malaise (2359); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 02/26/2021
Event Type  malfunction  
Manufacturer Narrative
Concomitant products: product id: neu_ptm_prog, serial#: unknown, product type: programmer, patient. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer and healthcare provider via manufacturer representative regarding a patient who was receiving clonidine (concentration: 100 mcg/ml, dose rate: 42. 46 mcg/day) and dilaudid (concentration 10 mg/ml, dose rate: 4. 246 mg/day) via an implantable pump for spinal pain. It was reported that the patient had their pump replaced this morning ((b)(6) 2021) and everything went well. The patient was home now and had stated that their pump was alarming. The company representative checked session long report from the procedure and noted that the pump had a pending alarm. The company representative was not with the patient.   at the time of the report it was reviewed that the pump needed to be interrogated to confirm the alarm.   the patient was described as very angry and wanted to know why the pump was alarming.   the pump was alarming every 20 minutes.   the ptm was checked and there were no alarms noted. The patient was hearing the alarm about every 3 to 5 minutes.   the patient was in pain. The personal therapy manager (ptm) was not connecting with the pump.   the ptm was however connected to the pump at the time of the call as the patient was reading the lockout time remaining during the conversation.   the patient described that the alarm they were hearing was a long tone such as a heart monitor when a patient is flatlining.   at the time of the report it was being considered that this was not a sound the pump has.   alarm intervals were reviewed.   the patient however insisted it was her pump.   it was further indicated that even though the ptm said its working, that it may not be. The patient stated she had a defective pump.   the patient refused to move to other locations of her home to see if she would hear the alarm.   the patient also noted that since they got home from the hospital and was hearing the pump alarming, she had been able to give herself 2 boluses.   the patient was not feeling well, was in pain, and could hardly breathe.   the company representative talked to the patient again later on (b)(6) 2021 and the patient was seeing the pump not found message on their personal therapy manager.   the patient's physician had advised the patient to go to the emergency room (er), but the patient said no because they were not going to help her.   they called the patient back again, and by this time the patient had indicated that they were connected and that their ptm was saying she had 3 plus hours remaining.   the patient had got locked out again without receiving a bolus.   while they were on the phone with the patient, a loud alarm went off. The alarm did not sound like the critical alarm.   the patient was agitated and convinced it was the pump regarding the alarm heard. The patient confirmed they had no other kind of medical equipment and the patient was in her bedroom. The patient wanted to contact their physician and the company representative had agreed.   on (b)(6) 2021 the company representative further reported the patient had called with withdrawal.   the company representative was to see the patient and was going to check the pump.   it was further noted that the physician might do a dose adjustment.
 
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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 Key11407590
MDR Text Key234723411
Report Number3004209178-2021-03634
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,Followup,Followup
Report Date 04/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2021
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
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/01/2021
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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