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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 Increase in Pressure (1491); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving prialt (5 mcg/ml at an unknown dose) via an implantable pump for an unknown indication for use. It was reported that during a pump replacement for end of service (eos), the surgeon found the pump in a deformed status. It was stated that up until now the pump was working in good order. The patient reported that they were scuba diving down to 50 m. No problems during or after diving were found. The event date was unknown. The hcp was inquiring whether the deformation led to a change in the flowrate/dose, or if the pump worked as programmed. It was reported the pump was replaced not because of the deformation, but because of the eos status ((b)(6) 2019); the replacement occurred on (b)(6) 2018. It was also stated that surgical intervention did not occur nor was planned. The issue was resolved. The patient status was alive - no injury. The pump would be returned. There were no reported symptoms. No complications were reported or anticipated.
 
Manufacturer Narrative
Analysis of the pump identified a concave shield that affected in-vivo function. Fdm updated. Fdr updated. Fdc updated. 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 Key8142320
MDR Text Key129784906
Report Number3004209178-2018-27141
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2012
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2011
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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