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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Pumping Stopped (1503); Failure to Deliver (2338)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
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 foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving an unknown drug via an implantable pump for an unknown indication for use. It was reported an error code indicating "pump stopped - code security or code safety" was received. The representative provided an image of an physician programmer error message. The error message indicated the pump had stopped due to safety count. There were no reported symptoms. No complications were reported or anticipated. The initial reporter and serial number of the pump were provided. It was unknown on what date the error message was seen. The drug being delivered at the time of the event was unknown. It was unknown what actions were taken to resolve the issue. Additional information was received. It was stated it was unknown when the pump was implanted. The pump was explanted in (b)(6) of 2018. When asked why the pump was explanted, the representative stated, "it was reported an error code indicating "pump stopped - code security or code safety" was received. The representative provided an image of an physician programmer error message. The error message indicated the pump had stopped due to safety count. There were no reported symptoms. No complications were reported or anticipated. ".
 
Manufacturer Narrative
Review of the initial interrogation of the pump indicated the pump had been delivering morphine (2. 7 mg/ml), ropivacaine (9. 2 mg/ml), and ziconotide (0. 9 mcg/ml). Analysis of the product has not been completed as of the date of this report. A follow-up report will be submitted when analysis is complete. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Updated to adverse event product problem. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis of the pump identified no anomalies. (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.
 
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)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7704648
MDR Text Key114537103
Report Number3004209178-2018-16237
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeFR
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 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2018
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? Yes
Date Device Manufactured04/27/2017
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: 07/19/2018 Patient Sequence Number: 1
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