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Model Number IN-PEN
Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Date 05/26/2021
Event Type  malfunction  
Event Description
Medtronic received information that leadscrew anomaly occurred. There was no adverse impact or consequence reported as a result of this event.
Manufacturer Narrative
This report is part of a retrospective review and remediation efforts in response to a warning letter. Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge. Medtronic, inc. (medtronic) is submitting this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation. This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda. Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report. This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned". These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803. Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms. This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Manufacturer (Section D)
18000 devonshire st.
northridge CA 91325
Manufacturer (Section G)
18000 devonshire st.
northridge CA 91325
Manufacturer Contact
tricha miles
18000 devonshire st.
northridge, CA 91325
MDR Report Key13812973
MDR Text Key297529775
Report Number2032227-2022-150336
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation
Type of Report Initial
Report Date 03/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIN-PEN
Device Catalogue NumberIN-PEN
Was Device Available for Evaluation? No
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown