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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 Electromagnetic Interference (1194); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Additional review of this mdr determined that there is no information to reasonably suggest that the device in this report may have caused or contributed to a serious injury and there is no information to reasonably suggest that the device resulted in a repo rtable malfunction. Therefore, this event no longer meets the reporting requirements stipulated in 21 cfr 803. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received via a company representative. It was clarified that the company representative was paged by the hospital to read the pump regarding a routine post magnetic resonance imaging (mri) check. Actions taken included having read the pump logs after 4 hours and the logs noted the motor stall recovery had occurred. The motor stall recovered approximately at 5 pm / 4 hours post mri. The motor stall that occurred following the mri was resolved. The event did not result in any impact to the patient. The patient¿s weight at the time of the event was noted as having been asked but was unknown.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a company representative regarding a patient who was receiving an morphine with concentration 15 mg/ml at a dose rate of 0. 721 mg/day via an implantable pump for spinal pain. It was reported that the patient had magnetic resonance imaging (mri) performed on (b)(6) 2018. A motor stall was seen at initial interrogation. No motor stall recovery had occurred. It had not been less than 2 hours since the patient exited the mri field. Periodically interrogating the pump for stall recovery was being considered. No patient symptoms were reported. No further patient complications have been reported as a result of this event.
 
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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 Key7455633
MDR Text Key106625750
Report Number3004209178-2018-08732
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,Followup
Report Date 04/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2019
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 Received04/24/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/16/2017
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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