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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 Difficult to Advance (2920); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 13-nov-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) via a company representative regarding a patient receiving morphine (1 mg/ml at an unknown dose) via an implanted pump. The indication for pump use was not provided. On (b)(6) 2018, during the implant procedure, the catheter got stuck in the needle hub and the stylet poked through the end of the catheter. The environmental, external, or patient factor that may have led or contributed to the issue was noted to be that the needle was placed at a steep angle to gain access to the intrathecal space. The catheter started advancing caudal. The physician then removed the needle to pull the catheter back out to reposition when he could not pull the catheter out of the needle hub and noticed the stylet poking through the catheter at the end of the needle. The catheter was not implanted. Instead, a new catheter was grabbed/used and the next needle placement was much more shallow than the first. The issue was resolved. It was indicated that the hcp had no further information to provide regarding the event. No patient symptoms were reported. The patient status was reported as ¿alive ¿ no injury¿. No further complications were reported/anticipated.
 
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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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8169472
MDR Text Key130676635
Report Number3004209178-2018-27793
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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