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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 Volume Accuracy Problem (1675); Improper Flow or Infusion (2954)
Patient Problems Nausea (1970); Swelling (2091); Discomfort (2330); Weight Changes (2607)
Event Date 01/02/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider (hcp) via a clinical study regarding a patient receiving bupivacaine 10mg/ml for a total dose of 1. 727mg/day and morphine 5. 5mg/ml for a total dose of 0. 9499mg/day via an implantable pump for non-malignant pain and failed back surgery syndrome. It was reported the patient had tenderness and nausea resulting in weight lost post-surgery. The symptoms have resolved on their own. It was noted there was swelling above the pump and examination on (b)(6) 2018 revealed 8mls of serosanguinous fluid was aspirated. It was also noted that 0. 8mls serosanguinous fluid was aspirated (note: this is conflicting information). The device diagnosis was a pump reservoir volume discrepancy. The outcome of the event was noted to have resolved without sequelae on (b)(6) 2018. The etiology of the event indicated the relationship of the event to the device or therapy was possibly related and indicated the relationship of the event to the implant procedure was possibly related. The event date was (b)(6) 2018. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from healthcare professional via a clinical study indicated that the clinical diagnosis was tender pocket and volume discrepancy. The etiology was noted to be related to surgery/anesthesia. No further information was reported/anticipated.
 
Manufacturer Narrative
Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional via a clinical study indicated the clinical diagnosis was update to tender pump pocket. No further complications were reported.
 
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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 Key7498075
MDR Text Key107710684
Report Number3004209178-2018-10432
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2019
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/17/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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