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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 Failure To Service (1563); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2018
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 healthcare professional (hcp) regarding the patient¿s implantable drug infusion device. The drug being delivered was 150 mcg/ml dilaudid (hydromorphone) at 30 mcg/day. The reason for use was non-malignant pain and degenerative disc disease. It was reported that the patient¿s pump was empty as the pump ran out of medication in (b)(6) of 2018. They did not have access to the patient or an 8840 programmer. The patient had relocated and is having trouble finding a new physician. A phone number was provided for the patient to call patient services because the patient did not have an hcp. There were no symptoms reported. There were no further complications reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the hcp on 2018-jun-07. It was reported that the patient was still trying to find a place to fill the empty pump. The hcp stated that the patient contacted the device manufacturer, and the device manufacturer was unable to help them. The patient¿s weight was reported. There were no further complications reported/anticipated.
 
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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 Key7565583
MDR Text Key110047158
Report Number3004209178-2018-12476
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
Type of Report Initial,Followup
Report Date 06/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2014
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received06/07/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/22/2013
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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