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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 8637-20
Device Problems Pumping Stopped (1503); Failure to Deliver (2338)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 03/15/2018
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 healthcare professional (hcp) via a company representative regarding a patient receiving gablofen (200 mcg/ml at 234 mcg/day) via an implanted pump. The indication for pump use was intractable spasticity. It was reported that the patient had a pump refill on (b)(6) 2018. At that time, the pump logs showed that a motor stall occurred on (b)(6) 2018 and no recovery took place. But when the pump was interrogated at the refill on (b)(6) 2018, it showed a recovery occurred. At the refill, the pump aspirated back the correct amount of drug as if it was working and the patient never had a return of symptoms. It was noted that if the pump had stalled and not recovered it should have returned 19. 3 cc as stated in the telemetry, but instead it aspirated back 3 cc. Therefore, it was thought that the pump stalled and recovered in march but did not show the recovery in the logs until the pump was interrogated in july. The pump was replaced. The issue was resolved at the time of the report. The patient status w as reported as ¿alive ¿ no injury¿. With regards to if there were any environmental, external, or patient factors that may have led or contributed to the issue, ¿n/a¿ was noted. It was noted that the hcp had no further information regarding the event. No further complications were reported/anticipated.
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received and the logs showed stopped pump period may exceed tube set on (b)(6) 2018. No rotor or dye study was performed. The patient recovered without sequela. No further complications were reported or anticipated.
 
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.
 
Manufacturer Narrative
Analysis of the pump revealed no anomaly. 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 Key7732421
MDR Text Key115456528
Report Number3004209178-2018-16951
Device Sequence Number0
Product Code LKK
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 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
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? Yes
Date Device Manufactured05/27/2015
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: 07/30/2018 Patient Sequence Number: 1
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