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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 Problem Mechanical Jam (2983)
Patient Problem Pain (1994)
Event Date 05/25/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient who was currently receiving baclofen with concentration 3000. 0 mcg/ml at a dose rate of (b)(4) ¿mg/day¿ and dilaudid with concentration 1. 0 mg/ml at a dose rate of (b)(4) mg/day via an implantable pump for intractable spasticity and other spasticity. A friend/family member of the patient reported that the patient was in a lot of pain. Excruciating back pain was further noted. The pain was described as having been there for a while but had got worse within the last 3 to 4 days beginning on (b)(6) 2018. The date (b)(6) 2018 is considered an approximate date of event (specific month and year known only). The pain had gotten really bad on (b)(6) 2018 the patient had been hospitalized because of the excruciating pain on (b)(6) 2018 and was still currently in the hospital. It was noted that the hospital had given all kinds of pain medicine to the patient. Magnetic resonance imaging (mri) was performed on (b)(6) 2018, overnight. The reason for the mri was to diagnose the patient¿s back pain which was indicated as not having been related to the patient¿s device. The reporter did not think the patient¿s pain was related to the device. The reporter was calling to ask about checking the pump post mri. It was indicated that they did not know if the pump turned itself back on or not. The patient was not scheduled to see their healthcare provider (hcp) until the (b)(6). The option of having the hospital request a company representative come to check the pump if needed was being considered. The reporter was redirected to the patient¿s hcp. At the time of the report, it was noted that there was no record of any call(s) from the hospital to the manufacturer made before the mri. 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)
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 Key7562791
MDR Text Key109880071
Report Number3004209178-2018-12423
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 06/01/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/28/2014
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 Received05/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/28/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/01/2018 Patient Sequence Number: 1
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