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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 Problems Material Integrity Problem (2978); Insufficient Information (3190)
Patient Problem Seroma (2069)
Event Date 03/14/2022
Event Type  malfunction  
Event Description
Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving unknown drug via an implantable pump. It was reported the patient's pump was aspirated, on (b)(6) 2022, and 8 cc of clear cerebrospinal fluid was aspirated from the catheter implant site. A seroma at the catheter implant site was noted. A sample was sent to the lab for cultures. A catheter dye study was performed and showed the catheter was cut or dislodged with csf pooling. It was indicated the event was related to the device or therapy. The event was ongoing. Additional information was received from a healthcare provider via a clinical study indicated that the collected fluid was tests and no signs of an infection were noted.
 
Manufacturer Narrative
Concomitant medical products: product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter. Other relevant device(s) are: product id: 8598a, serial/lot #: (b)(4), ubd: 06-jun-2021, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
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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 Key13891797
MDR Text Key290572722
Report Number3004209178-2022-03715
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 Study,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/07/2019
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: 03/24/2022 Patient Sequence Number: 1
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