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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 Electromagnetic Interference (1194); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/28/2017
Event Type  malfunction  
Manufacturer Narrative
Corrected information: sex, date of birth. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider on (b)(6) 2017 regarding a patient's implanted infusion pump containing clonidine (2000mcg/ml at 119. 8mcg/day) and unknown baclofen (1000mcg/ml at 59. 9mcg/day). The indication for use was intractable spasticity. It was reported that the patient underwent magnetic resonance imaging (mri) for a reason unrelated to the device or therapy on (b)(6) 2017 at 11:00am. A motor stall occurred at 11:20am, and had not recovered by 02:21pm. It was reviewed that the pump should continue to be checked for recovery, and it was recommended that the patient be medically managed if necessary. No patient symptoms were reported, and no further complications were reported or anticipated.
 
Manufacturer Narrative
(b)(4) no longer applies. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a healthcare provider on 2017-mar-30. It was reported that 5 hours after the mri, the pump still had not recovered. The patient had no symptoms of withdrawal. The pump was interrogated multiple times, and the patient was managed medically. On (b)(6) 2017, the motor stall was noted to have recovered within 24 hours of the stall. The situation was considered resolved.
 
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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 clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6443061
MDR Text Key101392533
Report Number3004209178-2017-06597
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
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 04/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0591-2009

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