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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 8637-20
Device Problems Obstruction of Flow (2423); Difficult to Advance (2920); Infusion or Flow Problem (2964)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/08/2019
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8709sc, serial #: (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2019, product type: catheter. Product id: 8780, serial #: (b)(4), product type: catheter. Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 14-jul-2013, udi#: (b)(4). Product id: 8780, serial/lot #: (b)(4), ubd: 19-apr-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a company representative regarding a patient receiving gablofen (2000 mcg/ml at 450 mcg/day) via an implanted pump. The patient¿s medical history included numerous other medical as well as spinal issues. The indication for pump use was cerebral palsy and intractable spasticity. On (b)(6) 2019 it was reported that the physician went to do a pump replacement due to normal service life and couldn¿t aspirate csf (cerebrospinal fluid) during the replacement. The physician felt that all the holes in the catheter were ¿plugged¿ and questioned whether it might be granuloma-related, although there were no symptoms reported. She ended up removing the catheter and was going to replace it but couldn¿t get csf during the replacement process either so questioned whether the patient was getting any benefit and elected to abandon the catheter replacement and remove the pump, not replace it. It was also reported that when they were trying to place the new catheter, they could only get it to the t-3 level which was where the last catheter tip was. The physician was ordering an mri to see if they could determine w hy they couldn¿t get csf and had difficulty placing the catheter. Additional information was received on (b)(6) 2019 at which time it was reported that the mri was never done. The patient had trach issues and then got sick with pneumonia. The patient¿s mom did not want a replacement pump, so they were not planning an mri at this point or replacement of the pump in the future. The cause for the difficulty placing the catheter remained unknown. No further complications were reported/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 Key8254478
MDR Text Key133271154
Report Number3004209178-2019-01142
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 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/14/2013
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received01/08/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/23/2011
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: 01/16/2019 Patient Sequence Number: 1
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