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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 Obstruction of Flow (2423); Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/24/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant products: product id: 8780, serial# (b)(4), product type: catheter. Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 20-jul-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 gablofen (500 mcg/ml at 50 mcg/day) via an implanted pump. The indication for pump use was cerebral palsy and intractable spasticity. It was reported that during the initial implant procedure of the pump and catheter on (b)(6) 2018, the catheter was kinked during the implant attempt. Once kinked, it made it difficult to implant, so the hcp requested a second catheter which was able to be implanted without issue. The catheter that kinked was not implanted. No patient symptoms were reported. The issue was resolved. The patient status was reported as ¿alive ¿ no injury¿. There were no reported environmental, external, or patient factors that may have led or contributed to the issue and it was indicated that the hcp had no further information to provide regarding the event. No further complications were reported/anticipated.
 
Manufacturer Narrative
Analysis of the catheter revealed catheter body damage occurred to catheter body and or guidewire during implant procedure. 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key8004107
MDR Text Key125317497
Report Number3004209178-2018-23857
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 01/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/28/2020
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/09/2018
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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