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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 Problems Fluid Leak (1250); Infusion or Flow Problem (2964); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seroma (2069)
Event Date 04/14/2022
Event Type  Injury  
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving bupivacaine (10 mg/ml at 1. 32 mg/day) via an implantable pump for spinal pain indications. It was reported that the patient experienced fluid collection in the pump pocket. There were no known factors that may have led or contributed to the issue. The physician dissected to expose the pump and no frank leakage was noted. There was sluggish aspiration at the cap (catheter access port) but the catheter cleared. The hcp disconnected the catheter connector from the pump and noted connector misshapen. A new pump connector was spliced to remaining spinal segment and calculations for catheter length corrected in settings. Upon aspiration of catheter post connection, more robust aspiration was noted. The pocket was irrigated and the pump was replaced.  the issue was resolved at the time of report. The patient's status at the time of report was alive - no injury.
 
Manufacturer Narrative
Concomitant medical products: product id: 8780; serial#: (b)(4); implanted: (b)(6) 2021; explanted: (b)(6) 2022; product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 15-jan-2023, 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 Key14146286
MDR Text Key290467230
Report Number3004209178-2022-04966
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
Report Date 04/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
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 Received04/19/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/04/2021
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: 04/19/2022 Patient Sequence Number: 1
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