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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 Volume Accuracy Problem (1675); Improper Flow or Infusion (2954)
Patient Problems No Consequences Or Impact To Patient (2199); Therapeutic Response, Decreased (2271)
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 professional (hcp) via a manufacturer representative regarding a patient who was receiving morphine (50 mg/ml)at a dose of 60 mcg/day via an implantable pump for an unknown indication for use. It was reported on (b)(6) 2018 that the patient experienced withdrawal symptoms and that the reservoir volume (noted to be 21. 2 ml) was not the same as the possible aspired volume on an unknown date. Diagnostics/troubleshooting performed was asked but unknown. The pump was replaced on (b)(6) 2018 as actions/interventions taken to resolve the issue and the pump would be returned. At the time of the report the issue was resolved and the patient status was ¿alive ¿ no injury. ¿ the patient¿s age, weight, gender, and medical history was asked but would not be made available. No further complications were reported or anticipated.
 
Manufacturer Narrative
Pump interrogation at medtronic european operations center indicated the pump was delivering sufentanil [50. 0 mcg/ml]. 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 MN 00777 1200
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos,pr MN 00777 1200
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7721920
MDR Text Key115086384
Report Number3007566237-2018-02216
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2018
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 Manufactured02/10/2018
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: 07/26/2018 Patient Sequence Number: 1
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