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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 Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2018
Event Type  Injury  
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed the pump was returned for analysis and upon device interrogation the pump was used to infuse baclofen 2,000. 0 mcg/ml at 1,050. 1 mcg/day if information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via company representative regarding a patient receiving drug via an implantable pump. The drug being delivered via the device system was not reported. The indications for use were intractable spasticity and spinal cord injury/spinal cord disease. It was reported that on (b)(6) 2018 the company representative received a text from the healthcare provider who stated that the pump would have to be replaced due to a motor stall with no recovery. Per the company representative the patient had a mri of the spine on (b)(6) 2018. The pump had stalled and never recovered. The patient had an mri the same day as the motor stall according to the logs. The reporter was unsure of the time of the mri but knew that patient had an mri the same day the pump had stalled. The reporter also did not have the time that the motor stall occurred. The cause of the motor stall with no recovery was unknown/not determined and was why the pump was being sent back for analysis. Per the company representative the patient was having compliance issues and was not making the physician aware of when they were having multiple mris or when the mris were scheduled, so it was unknown if the motor stall was due to mri or not. Per the reporter all they knew is that the patient had an mri the same day as the motor stall. The reporter also stated that the patient stated that their pain was getting worse, but the pump was not implanted for pain. The pump was implanted for spasticity and the patient's spasticity was fine. The patient¿s weight was noted to be between (b)(6) no further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Analysis of the pump revealed no significant anomaly; pump exterior impact dents, did not affect infusion. 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7592388
MDR Text Key110783444
Report Number3004209178-2018-13214
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00643169100824
UDI-Public00643169100824
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
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 07/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/12/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2016
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/05/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/04/2015
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: 06/12/2018 Patient Sequence Number: 1
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