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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 Nonstandard Device (1420); Pumping Stopped (1503); Failure to Deliver (2338); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/29/2018
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 regarding a patient receiving bupivacaine and dilaudid, dose and concentrations not reported via an implantable pump. The indications for use were non-malignant pain and chronic low back pain. On (b)(6) 2018 the patient reported that they had a refill last wednesday and today she tried to deliver a bolus and couldn¿t as she was seeing a code on the ptm (personal therapy manager); code 8476 (motor stall) and sees a bell on the ptm. The patient had heard the alarm and the agent played the pump alarms and the patient confirmed she was hearing the single tone beep (non-critical alarm). The alarm was heard on (b)(6) 2018. There were no patient symptoms reported and the patient was to follow up with their healthcare provider to have the pump/event logs checked to determine why the pump was alarming. No further complications were reported regarding the event.
 
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.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the consumer via the manufacturing representative 2018-aug-10. It was reported the patient was receiving 15 mg/ml of dilaudid at 4 mg/day. The patient reported the pump had alarmed because it reached end of service (eos). The pump was replaced on (b)(6) 2018. The issue had been resolved at the time of the report. The patient's status was provided as "alive - no injury. " other medications being taken at the time, patient weight, and medical history were not available.
 
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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 Key7734684
MDR Text Key115942858
Report Number3004209178-2018-17010
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,consum
Reporter Occupation
Remedial Action Recall
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 Received07/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2013
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 Manufactured01/16/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0497-2013

Patient Treatment Data
Date Received: 07/31/2018 Patient Sequence Number: 1
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