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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 Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)
Patient Problems Dyspnea (1816); Overdose (1988); Pain (1994); Respiratory Distress (2045); Complaint, Ill-Defined (2331); Sweating (2444); Sleep Dysfunction (2517); Cognitive Changes (2551)
Event Type  Injury  
Manufacturer Narrative
Consumer (non-healthcare professional). 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 10 mg/ml of hydromorphone at 1. 14 mg/day and 1. 5 mg/ml of bupivacaine at 0. 1710 mg/day via an implantable pump for non-malignant pain and post lumbar laminectomy syndrome. It was reported the patient could feel their pump malfunction a couple days earlier (relative to the date of the report, (b)(6) 2018). The patient went for a walk and started feeling very drugged up. The patient stated he did not hear any alarms coming from his pump. No interventions were reported. The patient reported they were trying to work with their healthcare provider. The patient reported experiencing sweating, snoring while sleeping, difficulty breathing, and having to ¿push to urinate. ¿ the patient sated he started to feel much better the day before after exercising and was trying to push through it. The patient stated this seemed to happen after getting refilled. The patient did not know when their last refill was. The patient stated they get refilled every 90 days and their next refill would be on (b)(6) 2018. The patient indicated they were on hydromorphone, so they had difficulties concentrating. The patient reported there had been no medication change and they were not sick. The patient was at baseline. The patient reported they had gone through an overdose a couple of years ago as well (please refer to mfr report #3004209178-2014-17207). The patient reported they were on morphine, and but their pain was getting worse. The patient reported they were trying to tell their hcp they did not want to be doped up all the time. The patient just wanted to take hydrocodone or tramadol when they needed it. The patient stated they found out they were talking too much tramadol, like 8 a day, so they want to back off of that. The patient stated they were supposed to take hydrocodone, but he had not picked it up from the pharmacy yet. No further complications were reported or anticipated.
 
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 Key7758216
MDR Text Key116306755
Report Number3004209178-2018-17584
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100831
UDI-Public00643169100831
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
Report Date 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2015
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 Manufactured09/23/2013
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: 08/07/2018 Patient Sequence Number: 1
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