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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 Fluid Leak (1250); Infusion or Flow Problem (2964); Material Integrity Problem (2978)
Patient Problem Pain (1994)
Event Date 03/07/2022
Event Type  Injury  
Event Description
Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving morphine (40 mg/ml at 9. 009 mg/day) via an implanted pump. It was reported that the patient was placed on the surgery schedule today suffering possible withdrawal type symptoms and pain following the pump replacement procedure a few weeks ago. After opening the pump incision, the catheter was found to still be securely connected to the pump. The catheter was then disconnected from the pump, and it was discovered that there was no backflow. The hcp explored further and followed the catheter into the tissues to discover a small mass of granulated damp powder believed to possibly be the medication from the pump. He then decided to replace the catheter. The proximal end of the existing catheter including the cap all the way to the butterfly anchor was removed. He then opened a new catheter and proceeded to make a needle entry at interspace l2/l1. He guided the new catheter posterior to interspace t8/t9 and then secured it with an injection anchor. Substantial backflow was noted. Lastly, he located the old catheter at the butterfly anchor and folded it over and tied it off. There was no backflow before or after tying it off. The new catheter was tunneled around to the pump and connected before closing all incisions. The environmental, external, or patient factor that may have led or contributed to the issue was noted to be the recent pump replacement procedure. The issue was noted to be resolved, and it was indicated that the hcp had no further information to provide regarding the event.
 
Manufacturer Narrative
Concomitant products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2003, explanted: (b)(6) 2022, product type: catheter. Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 10-apr-2005, 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 Key13861500
MDR Text Key287688465
Report Number3004209178-2022-03604
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 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2022
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? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/13/2021
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: 03/23/2022 Patient Sequence Number: 1
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