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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 Problem Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2017
Event Type  Injury  
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.
 
Event Description
The pump was returned by an unknown source to the manufacturer for analysis on (b)(6) 2017. The returned pump logs indicated the device had been examined on (b)(6) 2017, with the last changing occurring on (b)(6) 2017. The logs indicated the elective replacement indicator (eri) occurred on (b)(6) 2017, with a message to replace the pump by (b)(6) 2017. No further information was provided.
 
Manufacturer Narrative
Analysis found that there was high resistance in the battery. Recent fda coding changes offer limited options for medical device evaluation conclusion coding. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional via a company representative regarding a patient receiving bupivacaine (10 mg/ml at 1. 2 mg/day) and morphine (10 mg/ml at 1. 2 mg/day) via an implanted pump. The indication for pump use was failed back surgery syndrome and non-malignant pain. On 03-oct-2017 it was reported that telemetry confirmed a non-critical alarm occurred due to eri (elective replacement indicator). The eri was premature and occurred sometime since the last pump refill in (b)(6) 2017. The reporter did not have the logs, but eri likely occurred (b)(6) 2017 based on the schedule to replace pump by date of (b)(6) 2017. The patient had no symptom change and did not report hearing an alarm. No further patient complications have been reported as a result of this event.
 
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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 Key6914475
MDR Text Key103136796
Report Number3004209178-2017-20580
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 company representative,health
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2012
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/29/2011
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

Patient Treatment Data
Date Received: 10/04/2017 Patient Sequence Number: 1
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