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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 Excess Flow or Over-Infusion (1311); Pumping Stopped (1503); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Application Program Problem (2880); Infusion or Flow Problem (2964)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)
Event Date 03/11/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_cath, lot# unknown, serial# unknown, implanted: unknown, explanted: n/a, product type catheter. Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown, ubd: unknown , udi#: asku. (b)(6). 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 10 mg/ml at 7. 495 mcg/day via an implantable pump for an unknown indication for use. It was reported that the patient experienced withdrawal symptoms and went to the hospital. It was reported that there were no environmental/external/patient factors that may have led or contributed to the issue that they were aware of. It was reported that a refill procedure was performed and the expected drug volume was 9. 4ml and the aspirated drug volume was 0. 0ml. It was reported that a sideport control was performed and approximately 1ml was aspirated from the sideport. A rotor control with x-ray control was programmed via the tablet (fill bolus of 0. 010ml in 1min) did not show any movement with x-ray picturing. A catheter visibility control was done via sideport with contrast agents was not successful, it was not possible insert fluid (contrast agents) via sideport. It was reported that the pump is now programmed on minimal flow. The issue was not resolved at the time of this report. It was reported that no surgical intervention was performed and it was unknown if any 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.
 
Manufacturer Narrative
Product id: neu_unknown_cath, lot# unknown, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. It was reported that the patient's age and weight would not be provided by the physician due to data security. It was reported that no empty pump alarm was mentioned by the patient. It was reported that pump logs were not available. It was reported that an explant of the entire system was performed on (b)(6) 2019. The explanted synchromed ii pump is still at the hospital's place, but will be returned for analysis. No further complications were reported and/or anticipated.
 
Manufacturer Narrative
Product id: 8780, lot# 0208920725, serial# n/a, implanted: (b)(6) 2015, explanted: (b)(6) 2019, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. It was reported that the catheter model was confirmed to be 8780 with a lot number of 0208920725. It was reported that the implant date of the catheter was (b)(6) 2015. It was reported that the patient's symptoms have been resolved. It was inquired if any messages indicated a motor stall were present when the pump was interrogation and it was reported that there were no messages. It was inquired if the correct date of the event was (b)(6) 2019, and it was reported that the date of being notified by the physician of this event was (b)(6) 2019. No further complications were reported and/or anticipated.
 
Manufacturer Narrative
Product id: 8780, lot# unknown, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via a foreign user report. It was indicated that there was a suspected catheter obstruction and "dysfunction" of the implanted drug pump. It was noted that the patient also experienced pain exacerbations.
 
Manufacturer Narrative
Analysis of the pump identified damage to the septum, however, it did not result in a leak during bench testing in the laboratory. Analysis of the catheter identified an occlusion in the pin connector which is consistent with dried drug, blood or other foreign material. (b)(4). 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 Key8425638
MDR Text Key139073338
Report Number3004209178-2019-05380
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 07/10/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2015
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2014
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: 03/15/2019 Patient Sequence Number: 1
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