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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND

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MEDTRONIC PUERTO RICO OPERATIONS CO. PUMP MMT-1715KM 630G 3ML BLACK MEDI   ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND Back to Search Results
Model Number MMT-1715KM
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems High Blood Pressure/ Hypertension (1908); Unspecified Heart Problem (4454)
Event Date 05/09/2018
Event Type  Death  
Manufacturer Narrative
"this report is part of a retrospective review and remediation efforts in response to a warning letter. Z-0955-2020. (b)(4). S/w 2. 8c. The unit did not have a battery installed when received. Unit passed the functional test, including the self test, sleep current measurement, active current measurement, rewind test, prime/seating test, basic occlusion test, occlusion test, force sensor test, displacement test and the dat test at 0. 08700 inches. Unit uploaded properly using carelink. Unit had a scratched case, pillowing keypad overlay and a cracked retainer. Data analysis: (date the customer was reported deceased as of (b)(6) 2018. ) the formatted history file lists data from (b)(6) 2018 to (b)(6) 2018. There was no data listed for june 2018. 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. ".
 
Event Description
Complaints text 07/10/2018 10:11:21 velasr4 initial notes: the customer called because she received a letter about additional info inquired what led up to the complaint. Customer response: the customer called to provide details about the customer's death deceased reporting per (b)(4). First and last name of person reporting event: mary smith. Best phone number to reach person reporting event: 770-224-8936. Relationship of person reporting event to the deceased: 14-year significant other. Reporting party is aware of the deceased event details. Cause of customer passing as indicated by reporting party: probable hypertension/cardiac disease. Location of customer¿s passing: stopped breathing at home, declared dead in er. Date customer was admitted to hospital, emergency room or hospice (if known): northside hospital-charity, (b)(6) 2018. Bg at time of admission to hospital, hospice and/or emergency room, (if known): doesnt know, bg in the morning was 121. Does reporting party indicate other health issues or illness that may have contributed or led up to passing? heart issues, diabetes was under control, was overweight. Does reporting party recall the initial onset or timeframe of health issue or illness? the caller stated he had stage 4 kidney problems, it had been happening for a while, but the caller did not provide details. Used a catheter for about the last 5 years. Was pump worn at the time of passing? no. The caller stated he fell after he took a shower: he removed the pump to shower, then had the health issues date the pump was last worn:(b)(6) 2018. Reason customer was not wearing pump at time of deceased event: took the pump off to shower. Does reporting party know if customer was off pump therapy due to other health issue or illness? took the pump off to shower. Pump material number: mmt-1715km. Pump serial number: (b)(4). Infusion set material number: mmt-397. Infusion set lot/batch: 5218676. Reservoir material number: mmt-332a. Reservoir lot/batch: hg2bfdb. Name of glucometer being worn or used (ascensia, lifescan, etc. ): ascensia. Was medtronic cgm included in diabetes therapy? no. Customer's outcome pertaining to the complaint: -added additional notes -the customer had a letter from ccs to return the pump to them. Advised the caller to contact ccs about the letter she received. Ship: nothing / return: nothing ____________________complaints text (b)(6)2018 08:48:10 reyesd11 tried to contact next of kin, unable to make contact as working numbers on file are no longer in service. The medtronic helpline solutions team will not make any additional attempts to contact the customer¿s next of kin. Complaints text (b)(6) 2018 11:22:40 xiongl7 found customer's obituary online (http://www. Huntingtoncountytab. Com/obituary/48673/dr-deloss-brubaker). Updated incident date to reflect dod, (b)(6) 2018. Updated warranty. Complaints text (b)(6) 2018 12:45:31 erp_rfc_user related svn (b)(4) complaints text (b)(6) 2018 12:38:03 tuccic1 attempted to contact next of kin, unable to make contact due to only phone number on account is a none working number. Ceasing all marketing comms, updating patients notes. I marked the account inactive/deceased. I voided the medtronic device/pump warranty to reflect the end date as the date the customer was reported deceased as of (b)(6) 2018 start of report cust is reported deceased by ccs medical rep. ----end of report----.
 
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Brand NamePUMP MMT-1715KM 630G 3ML BLACK MEDI  
Type of DeviceARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
ceiba norte ind. park #50 road
juncos 00777 -386
00777-3869
Manufacturer Contact
tricha miles
ceiba norte ind. park #50 road
juncos 00777--386
  00777-3869
7635140379
MDR Report Key15037734
MDR Text Key296045532
Report Number2032227-2022-288306
Device Sequence Number1
Product Code OZO
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 07/16/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-1715KM
Device Catalogue NumberMMT-1715KM
Device Lot NumberHG2F94K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2019
Date Manufacturer Received06/29/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown
Removal/Correction NumberZ-0955-2020

Patient Treatment Data
Date Received: 07/18/2022 Patient Sequence Number: 1
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