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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 Kinked (1339); Migration or Expulsion of Device (1395); Volume Accuracy Problem (1675); Aspiration Issue (2883)
Patient Problems Muscle Spasm(s) (1966); Muscle Weakness (1967)
Event Type  Injury  
Manufacturer Narrative
Continuation of medical devices: product id 8709sc, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type catheter. Information references the main component of the system. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 18-nov-2013, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was provided by a healthcare provider(hcp) via a manufacturer regarding an implantable intrathecal pump intended to del iver gablofen [500 mcg/ml] at 250 mcg/day, indicated for intractable spasticity and stroke. On (b)(6) 2018, it was reported that the patient had been complaining of slowly increasing spasticity for approximately the last three months. The event date was asked but would not be made available due to a legal/confidential reason. The hcp did a side-port aspiration on (b)(6) 2018 was negative, they were unable to draw back any fluid. It was also noted that on the last refill, the expected reservoir volume (erv) was 3. 6 ml and the actual reservoir volume was 9 cc, so the hcp is thinking there is some sort of kink in the catheter not allowing for full flow. It was noted that all other expected versus actual at the time of refill had been normal. It was indicated that there were no environmental, external, or patient factors that may have led or contributed to the issue. As an action/intervention, the patient was scheduled for a catheter revision on (b)(6) 2018. The issue was not resolved at the time of the report. Surgical intervention was scheduled but had not yet occurred. The patient's status at the time of the report was listed as ¿alive ¿ no injury. ¿ the patient¿s medical history and weight were asked but would not be made available due to a legal/confidential reason. Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer. Additional information was received on (b)(6) 2018. It was reported that the patient was taken to the operating room (or) for exploration and revision of the catheter. The surgeon also decided to replace the pump since it was implanted in 2012. It was reported that the catheter was found to be pulled out of the intrathecal space and was in the subcutaneous tissue. It was indicated that it was unsure how or when this happened. The v-wing anchor was still attached to the fascia. The patient reported never experiencing withdrawal symptoms. Per the patient, they experienced fluctuating tone over the last few months, but no withdrawal. The old pump and catheter were both completely removed and replaced. The new pump was filled with lioresal [500 mcg/ml] and restarted at a dose of 100 mcg/day, per the managing hcp. It was noted that the hospital has possession of the explanted products. They were asked to return to the manufacturer for analysis, but the hospital¿s policy is that the devices go to gross, so it was unknown if they would be returned. It was noted that the patient had a follow-up appointment with their managing physician scheduled for (b)(6) 2018. No further co mplications 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 Key7646348
MDR Text Key112623144
Report Number3004209178-2018-14570
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
Report Date 06/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/29/2012
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: 06/28/2018 Patient Sequence Number: 1
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