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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Electromagnetic Interference (1194); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2017
Event Type  Injury  
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 consumer via a manufacturer representative (rep) regarding a patient who was receiving a concentrate on of 2000 mcg baclofen at a dose of 723 mcg and a concentration of 2. 0 mg marcaine at a dose of 1. 7 mg via an implantable pump for intractable spasticity. It was reported that the patient had an mri on the cervical, thoracic, and lumbar spine. Then they went to check the pump after the mri and the motor stall did not recover. It was noted they tried multiple programmers. The mri may have led or contributed to the issue. They waited 1 hour after the mri, changed the alarm date volume from 1 mg to 2 mg and hit update; re-read the pump with no change; changed the clock on the pump, updated and re-read the pump with no change; then came back to read the pump 3 hours later and the pump still said "motor stall occurred" with no recovery. The patient was turned to minimum rate and was being monitored in the hospital. They were planning on replacing the pump, however it was not scheduled at this time. The event was unresolved and the patient was noted to be "alive - no injury". It was later reported that the patient had an mri on (b)(6) 2017 and when checked after mri, the system had returned to normal operating mode. The patient had another mri the next day and when read afterwards, the pump did not recover. It was further stated that the pump never recovered. The patient had no symptoms. It was noted the device was implanted in 2012 and the doctor had been working on getting the pump replaced. At the time, replacement had not been scheduled. No further complications were reported or anticipated.
 
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Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO
rd 31 km 24 hm 4
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6846764
MDR Text Key85090984
Report Number3004209178-2017-18861
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,consum
Reporter Occupation
Remedial Action Notification
Type of Report Initial
Report Date 09/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2014
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received08/14/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/08/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-0592-2009

Patient Treatment Data
Date Received: 09/06/2017 Patient Sequence Number: 1
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