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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 Problem Premature Elective Replacement Indicator (1483)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/26/2017
Event Type  Injury  
Manufacturer Narrative
Interrogation of the pump found that it was delivering 20 mg/ml morphine at 3. 495 mg/day and 340 mcg/ml clonidine at 59. 42 mcg/day. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The device was returned to the manufacturer.
 
Manufacturer Narrative
Updated to reflect the report that a pump replacement is pending. Updated to reflect the information received on (b)(6) 2017. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received on (b)(6) 2017 from the patient's healthcare provider (hcp). It was reported that the patient's pump was refilled as scheduled. The cause of the premature eri was not determined. A replacement was not scheduled, but was pending. It was confirmed that the pump would be returned to the manufacturer once it is explanted. The patient's weight was provided. The issue was not considered resolved as replacement was pending. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a manufacturer's representative (rep). It was reported that the pump was replaced on (b)(6)2017 and would be sent back to the manufacturer for analysis.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider regarding a patient who was receiving an unknown drug at an unknown concentration and dosage via an implantable pump for non-malignant pain. On 2017-oct-02, it was reported that the patient's pump had undergone premature eri. A non-critical alarm occurred and eri occurred was confirmed through telemetry. At the patient's last refill appointment on (b)(6) 2017, the eri was at 32 months. The pump was interrogated on (b)(4) 2017 and eri was shown to have occurred on (b)(6) 2017. No symptoms were reported. No further complications were reported.
 
Manufacturer Narrative
Recent fda coding changes offer limited options for medical device evaluation conclusion coding. Medtronic selected conclusion code because, although the device meets design specification, corrective actions are focused on enhancements to the design making this the closest code available with respect to this event. Analysis of the implantable infusion pump (serial # (b)(4)) revealed electrochemical migration across the electrical feed-through insulator which caused an electrical short. The electrical short resulted in a low battery reset/motor stall. 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 Key6914058
MDR Text Key100960647
Report Number3004209178-2017-20598
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
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/26/2018
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 Date07/28/2014
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/07/2013
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: 10/04/2017 Patient Sequence Number: 1
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