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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 Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2020
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 8784, serial#: (b)(4), implanted: (b)(6) 2020, product type: catheter. Product id: neu_ptm_prog, serial#: unknown, product type: programmer, patient. Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 05-jun-2021, udi#: (b)(4). Product id: neu_ptm_prog, serial/lot #: unknown, ubd: 05-jun-2021. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) regarding a patient receiving unknown drugs via intrathecal infusion pump for chronic low back pain and non-malignant pain. It was reported the hcp wanted assistance programming the myptm app settings. It was reported that the hcp performed a catheter revision on (b)(6) 2020 and the company rep disabled the app. The patient was now going through withdrawal and had to go to the er. The hcp programmed a 0. 1mg single bolus and switched the dose from 0. 399mg/day to 0. 499mg/day. The app was enabled. The hcp programmed a 0. 004mg bolus with a max of 3/day.
 
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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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10886296
MDR Text Key217917082
Report Number3004209178-2020-20481
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2021
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/10/2020
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: 11/23/2020 Patient Sequence Number: 1
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