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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. ASCENDA PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8780
Device Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/08/2019
Event Type  Injury  
Manufacturer Narrative
The returned catheter was subjected to a series of standard tests that include but is not limited to visual inspection, patency testing, and pressure testing. Analysis identified an anomaly to the catheter/guide wire. As received for analysis, the guide wire was observed to be protruding through the distal portion of the catheter. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(6). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving an unknown drug via an implantable pump for an unknown indication for use. It was reported a catheter issue occurred on (b)(6) 2019. During the intervention, the catheter came out of its location when the surgeon wanted to retrieve the tuohy needle. "no traction effort" was done to retrieve the needle. It was stated surgical intervention occurred. The hcp used another catheter and the issue resolved. No troubleshooting was performed. There were no reported contributing factors. The patient status was alive - no injury. The catheter would be returned. There were no reported symptoms. Further complications were not reported. Additional information was received. It was stated the event occurred during an initial implant.
 
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Brand NameASCENDA
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 Key9734341
MDR Text Key188131993
Report Number3004209178-2020-03763
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeFR
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,Followup
Report Date 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/14/2021
Device Model Number8780
Device Catalogue Number8780
Device Lot Number0217781956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2019
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: 02/20/2020 Patient Sequence Number: 1
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