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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 Premature Elective Replacement Indicator (1483); Inappropriate or Unexpected Reset (2959)
Patient Problems Nausea (1970); Sweating (2444)
Event Date 09/25/2017
Event Type  malfunction  
Event Description
Information was received from a health care provider (hcp) regarding a patient with an implantable drug infusion pump indicated for non-malignant pain and degenerative disc disease. The pump contained fentanyl [6000 mcg/ml] at a dose of 3268 mcg/day. It was reported safe state and reset occurred. The hcp reported early replacement indicator (eri) also occurred. Troubleshooting done on the call included checking the pump logs. The pump logs showed eri occurred on (b)(6) 2017, and the low battery reset and safe state logs were 3 hours later. Reported symptoms included feeling nauseated. The patient also reported sweating, but the hcp reported she appeared to be in no distress. The last refill was on (b)(6) 2017, and the eri was estimated at 6 months. No further patient complications were reported.
 
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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 Key6901212
MDR Text Key87654152
Report Number3004209178-2017-20253
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 health professional
Reporter Occupation
Remedial Action Notification
Type of Report Initial
Report Date 09/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2012
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/27/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/03/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-3043-2011

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