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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); Insufficient Flow or Under Infusion (2182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2018
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 health care provider (hcp) via a device manufacturer representative regarding a patient receiving an unknown drug at an unknown concentration and dose via an implantable infusion pump. The indication for use was noted to be non-malignant pain. It was reported that on (b)(6) 2018 the hcp reported a volume discrepancy of: expected residual volume
=
0. 7 ml, actual residual volume
=
8. 0 ml. They also noted at a previous refill (on an unknown date) there was a volume discrepancy of 4. 4 ml. It was noted the patient was reaching efficacy and had no problems with their therapy. The hcp was considering troubleshooting options, but as the patient had no complaints, they decided against any actions at the time of the report. No further complications were reported. Additional information was received from a health care provider (hcp) via a device manufacturer representative on (b)(6) 2018. It was reported that the cause of the volume discrepancy was not determined. No further complications were reported. Additional information was received from a health care provider (hcp) via a device manufacturer representative on (b)(6) 2018. It was reported that the first volume discrepancy was recorded in (b)(6) 2018. The volumes were as follows - (b)(6) 2018: arv
=
8. 5ml, erv
=
2. 9ml, (b)(6) 2018: arv
=
7. 0ml, erv
=
0. 6ml, (b)(6) 2018: arv
=
9. 0ml, erv
=
2. 9ml, (b)(6) 2018: arv
=
6. 0ml, erv
=
1. 6ml, (b)(6) 2018: arv
=
9. 0ml, erv
=
0. 7ml. The cause was unknown. The patient's weight was provided. 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 Key7620493
MDR Text Key111864242
Report Number3004209178-2018-13874
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/14/2016
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received06/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/23/2015
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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