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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); Data Problem (3196)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 12/13/2017
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a company representative. The cause of the elective replacement indicator (eri) was unknown. The pump was replaced. The patient is out of medication withdrawal and doing well. The removed pump will not be sent back for analysis as is against the hospitals protocol.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a company representative regarding a patient who was receiving an unknown medication via an implantable pump. Indication for use was non-malignant pain and failed back surgery syndrome. Other medications the patient was taking at time of the event were not available. The date of the event was (b)(6) 2017. It was reported the patient experienced withdrawal. The pump was beeping. The pump was interrogated and was in safe mode; premature elective replacement indicator (eri) had occurred. The pump was being replaced (b)(6) 2017. The issue was not resolved. No environmental/external/patient factors may have led or contributed to the issue. Patient weight and medical history were asked and will not be made available. Patient status at time of this report was alive -no injury. No further complications were reported.
 
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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 Key7128056
MDR Text Key103218577
Report Number3004209178-2017-26240
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
Report Date 01/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2012
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 Received01/03/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/19/2010
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: 12/19/2017 Patient Sequence Number: 1
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