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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 Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 01-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 professional (hcp) via a company representative regarding a patient going to be receiving dilaudid (5 mg/ml at 500 mcg/day) via an implanted pump. During the initial device implant procedure on (b)(6) 2020, the physician could not get the catheter advanced past the needle tip. He pulled the needle out and the catheter did advance. He then attempted catheter advancement using the same needle, but the catheter would not advance. A new catheter was opened and that one also did not advance. He then tried a new needle and the catheter advanced easily. The pump was then implanted without issue. There were no environment factors that may have caused or contributed to the issue. The patient had no symptoms. The event occurred intra-operatively. The issue was resolved, and it was indicated that the hcp had no further information to provide regarding the event. The patient status was reported as ¿alive ¿ no injury¿. No further complications were reported/anticipated.
 
Manufacturer Narrative
Product id: 8780, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Product id: 8780, serial# (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2020, product type: catheter. Visual inspection identified damage/foreign material in the introducer needle. 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key9989708
MDR Text Key188676142
Report Number3004209178-2020-07563
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,Followup
Report Date 06/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/28/2021
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/03/2020
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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