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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 Infusion or Flow Problem (2964)
Patient Problem Muscular Rigidity (1968)
Event Date 05/17/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8784, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: catheter. Product id: 8780, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: catheter. Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 26-jan-2023, udi#: (b)(4); product id: 8780, serial/lot #: (b)(4), ubd: 05-feb-2023, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving gablofen (500 mccg/ml at 100 mcg/day) via an implantable pump for intractable spasticity. It was reported that the patient had been experiencing more and more spasticity since the initial implant. There were no factors that may have led or contributed to the issue. Logs were read and cap (catheter access port) aspiration was attempted on (b)(6) 2022 by managing healthcare provider staff. Cap aspiration was unsuccessful. The hcp was asked to revise the catheter on (b)(6) 2022. Upon examination, the hcp noted no spontaneous flow from the catheter nor was the hcp able to aspirate the catheter through the cap intra-operation. As the hcp worked from the pump back to the spinal incision making several cuts of the catheter to see if there was any flow. Not until the hcp pulled the catheter back quite a bit was the hcp able to see some dripping of csf (cerebrospinal fluid). The hcp decided at that point to replace the entire catheter as well as replace the pump even though there was no allegation of anything malfunctioning with the pump. The issue was resolved at the time of report. The patient's medical history was asked and will not be made available. The patient's status at the time of report was alive - no injury.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14465519
MDR Text Key292348322
Report Number3004209178-2022-06564
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2021
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: 05/21/2022 Patient Sequence Number: 1
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