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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 Filling Problem (1233); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182)
Patient Problems Pain (1994); Sleep Dysfunction (2517); Ambulation Difficulties (2544)
Event Date 01/01/2020
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 consumer regarding a patient receiving unknown drug via an implanted infusion pump. It was reported the patient's pump was out of medication as the patient was due to be refilled on (b)(6) 2020 but due to covid-19 the appointment was cancelled. The patient was rescheduled to see the hcp on (b)(6) 2020 to fill the pump but the patient cannot get a flight to their hcp. It was noted the critical alarm started last week but now the pump had stopped. It was noted the patient's back was hurting real bad since over 120 days ago. The patient was scheduled to see an hcp on (b)(6) 2020 but that doctor doesn't manage pump. The patient would like to find an alternate hcp in area to fill the pump.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2020-may-08, additional information was received from the patient. They reported they are not able to sleep, walk, or stand because their pump was empty and beeping. The patient went to their primary care physician (pcp) to try and find a pump doctor. The pcp found a pain doctor that could give injections. The pain doctor was also a pump doctor, but did not have a facility. The patient then stated they saw that pain doctor yesterday ((b)(6) 2020) so they could try and fill their pump with water. The doctor "could not get the opening" because of the way the patient was positioned. The doctor told the patient they were still looking for another pump doctor that would be able to help her. The patient stated they had received help from a manufacturer representative (rep) in finding another doctor. The drug listed in the pump was bupivacaine (unknown dose and concentration).
 
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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 Key10020511
MDR Text Key189730128
Report Number3004209178-2020-08041
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
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/14/2019
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 Received08/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/26/2017
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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