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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 8637-40
Device Problems Filling Problem (1233); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2015
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 on 2018-jun-19 regarding a patient receiving fentanyl (1688. 0mcg/ml at "1. 208. 5mcg/day"), hydromorphone (6mg/ml at 4. 2957mg/day), bupivacaine (30mg/ml at 21. 478mg/day), and prialt (2. 6mcg/ml at 1. 8615mcg/day) via an implanted infusion pump. The indication for use was non-malignant pain. It was reported that the patient's second pump had to be removed because the nurse tried to put medication into the pump, but couldn't get the medication in. The doctor tried and couldn't and then replaced the pump. No patient symptoms were reported and the event occurred in (b)(6) 2015. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the healthcare professional (hcp) on (b)(6) 2018. It was reported that ¿the information is incorrect. At no time has there been any difficulty accessing the fill port of his pump. ¿ it never happened. ¿the pump was not explanted for fill-port related issues. It was removed/replaced months later due to the battery being at its end of life. ¿ there were no further complications reported/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 Key7627172
MDR Text Key111976426
Report Number3004209178-2018-14055
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,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2013
Device Model Number8637-40
Device Catalogue Number8637-40
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 Manufactured11/29/2011
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: 06/21/2018 Patient Sequence Number: 1
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