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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 8637-20
Device Problem Infusion or Flow Problem (2964)
Patient Problem Muscular Rigidity (1968)
Event Date 05/02/2022
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2021, explanted: (b)(6) 2022, product type: catheter. The main component of the system. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 30-oct-2021, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare provider via a company representative regarding a patient receiving compounded baclofen 2000. 0 mcg/ml at 599. 9 mcg/day via an implantable pump. The patient¿s medical history stated ¿medical¿. Loss of therapy relief was reported. The patient was losing relief of her spasticity and felt this was due to the catheter not working properly. The environmental, external or patient factors that may have led or contributed to the issue was the patient had mentioned some falls in the previous month but there was no way of knowing if they were related to the therapy not being effective. The diagnostics and troubleshooting performed was the physician performed a dye study. At the dye study, the doctor was able to remove csf (cerebral spinal fluid) but unable to push the contrast through the catheter. The actions and interventions taken to resolve the issue was the catheter was replaced. The issue was resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the 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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14345010
MDR Text Key291278274
Report Number3004209178-2022-05947
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
Report Date 05/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/10/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/05/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/01/2021
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: 05/10/2022 Patient Sequence Number: 1
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