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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 8637-40
Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Sleep Dysfunction (2517); No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2019
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 consumer regarding a patient receiving fentanyl via an implanted pump. The indication for use was non-malignant pain. It was reported the patient was having a return of pain that started after refill on monday. The patient noted their refill date was (b)(6) 2020 when it usually lasts 6-8 months. It was noted the hcp went to the patient's house last night and had put in 50/50 mix instead of full strength. The patient was feeling great, but then woke up yesterday really hurting and it got really bad and could not sleep. It had turned into absolute misery. The patient's bridge bolus was 44 hours. The lockout info was 15x/day, 1x/60min, and 15x/24 hr. There was no out of box failure and the patient was re-directed to their hcp to check refill date, review lockout info, address pain. Additional information was received from the consumer and the hcp on 2019-dec-12. It was reported that the patient spoke with a company representative on (b)(6) 2019 who told the patient that there may be a malfunction within the ptm. It was determined that the ptm appears to be working as intended. The patient stated that they did not feel relief from the medication. The hcp re ported that the cause of the return of pain was a programming error on (b)(6) 2019. The pump was reprogrammed to reflect the correct concentration on (b)(6) 2019. The return of pain was considered resolved.
 
Manufacturer Narrative
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 Key9483016
MDR Text Key181830831
Report Number3004209178-2019-23993
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 consumer,health professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 12/20/2019
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? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/12/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/30/2017
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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