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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 Problems Premature Elective Replacement Indicator (1483); Shelf Life Exceeded (1567); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2018
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 foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving morphine 10mg/ml at 2,201 mg/day via an implantable pump for an unknown indication for use. It was reported that the premature elective replacement indicator (eri) alarm triggered on (b)(6) 2018. It was reported that there have been no problems at the refills and that the residual volumes were in accordance with the n'vision. It was reported that the patient is doing fine and has no side effects. It was reported that it was unknown if there were any environmental/external/patient factors that may have led or contributed to the issues. The pump logs were confirmed that eri occurred on (b)(6) 2018 and that the pump replace by date was 2018-aug-20. On (b)(6) 2018 an active alarm was silenced. It was reported that there was no diagnostics/troubleshooting performed. It was reported that there were no interventions/actions that were taken to resolve the issue. It was reported that the issue was not resolved at the time of this report. It was reported that no surgical intervention occurred and no surgical intervention was planned. The patient status at the time of the report was alive-no injury. No further complications were reported and/or anticipated. Additional information was received. It was reported that the implant was confirmed to be (b)(6) 2017. No further complications were reported and/or anticipated.
 
Manufacturer Narrative
Device code (b)(4) no longer applies to this event. Also, due to (b)(4) harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. It was reported that on (b)(4) 2018, the patient underwent surgery for a neurostimulator replac ement and not for a pump replacement. A review of the operating room (or) records indicated that they could not find any traceability of a pump replacement but only a neurostimulator replacement. It was reported that the pump was implanted in 2011. No further complications were reported and/or anticipated. Additional information was received. It was reported that it was confirmed with the physician that the pump was not replaced on (b)(6) 2017, but the ipg was replaced that day. No further complications were reported and/or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. It was reported that the implant was (b)(6) 2011. Information was asked regarding what the pump logs noted as the expected eri or months to eri at previous refills and it was reported that the information was asked to the physician and no answer was received. No further complications were reported and/or anticipated.
 
Manufacturer Narrative
Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury. 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.
 
Manufacturer Narrative
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 Key7625747
MDR Text Key111999039
Report Number3004209178-2018-14013
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeSZ
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,Followup,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2012
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/18/2011
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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