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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 Application Program Problem (2880); Insufficient Information (3190)
Patient Problems Pain (1994); Therapeutic Response, Decreased (2271); Distress (2329); Malaise (2359); Sweating (2444); Shaking/Tremors (2515)
Event Date 11/14/2019
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 (unknown concentration and dose) via an implantable pump for an unknown indication for use. It was reported there was a pump issue. The event date was (b)(6) 2020. The patient experienced pain increase. Catheter opacification was performed, but no problem was identified. A rotor test was performed; it was stated the test showed a problem with the pump, as the rotor did not turn as planned. The pump would be replaced on (b)(6) 2020. The issue was not resolved. It was stated no external factor had contributed to the issue. The patient status was alive - no injury. Further complications were not reported. Additional information was received. No issues were identified in the pump logs. The pump was successfully replaced on (b)(6) 2020 and the event resolved. The pump would be returned.
 
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. Pump interrogation at medtronic (b)(4) indicated the pump was delivering morphine 10. 0 mg/ml at a dose of 1. 998 mg/day. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis of the pump identified no anomalies. A review of the pump interrogation report indicated the pump had been delivering morphine 10. 0 mg/ml at 1. 998 mg/day. 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key9649564
MDR Text Key185520465
Report Number3004209178-2020-02242
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
Report Date 05/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/04/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/25/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2018
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: 01/30/2020 Patient Sequence Number: 1
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