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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Overdose (1988); Pain (1994); Dysphasia (2195); Complaint, Ill-Defined (2331)
Event Date 05/09/2018
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 consumer regarding a drug infusion device. The drug being delivered was morphine (unknown) with an unknown dose and concentration. The reason for use was non-malignant pain. It was reported that the patient "has spent the last couple days in the hospital¿ because they fell last thursday "and busted up her lip". The patient didn't receive help at the hospital "because of course they think she is a drug addict". The caller says that "it seems like she is taking too much medication even though she isn't, but she isn't even taking all of her pills, and she will be fine one minute and the next she will be slurring her words and all happy and then she will be ok again". This started "a couple months ago (prior to the call date of (b)(6) 2018) and its slowly progressed and then a few weeks ago it¿s gotten worse". The patient had a fall last thursday ((b)(6) 2018 ) "and she had a fall a month or 2 before that as well" (2018). No interventions were mentioned. The patient has a pump refill this thursday ((b)(6) 2018), and so it was reviewed that the healthcare professional (hcp) can call to page a manufacturer¿s representative (rep) to be at the appointment. The situation is being addressed by the hcp. There were no further complications reported/anticipated.
 
Manufacturer Narrative
Correction- hospitalization also applies. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7736408
MDR Text Key115646962
Report Number3004209178-2018-17078
Device Sequence Number0
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
Type of Report Initial,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Expiration Date11/14/2013
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/17/2012
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: 07/31/2018 Patient Sequence Number: 1
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