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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8731SC
Device Problems Difficult to Insert (1316); Material Integrity Problem (2978); Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/10/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal morphine at an unknown dose and concentration. The indication for use was not reported. It was reported that during catheter placement, the physician could not reach the subarachnoid space. The physician found that the catheter tip was deformed and bent. The tip of the tuohy needle bent during the procedure. It was clarified that both the catheter and the tuohy needle were bent. The customer discarded the catheter, and another kit was used; the procedure was performed with success. The issue was resolved. The patient's status was alive - no injury. There were no other issues reported with regards to why the physician could not reach the subarachnoid space. It was noted that the physician did not implant a pump, and currently the catheter was connected to an access port. No surgical intervention occurred, and no surgical intervention was planned. Information regarding the patient¿s gender, age, weight, medical history, and other medications was unavailable. No further complications were reported.
 
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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 Key9483738
MDR Text Key177128627
Report Number3004209178-2019-24005
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/17/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/10/2020
Device Model Number8731SC
Device Catalogue Number8731SC
Device Lot Number0216093993
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 Received12/05/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/10/2018
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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