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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 8637-20
Device Problems Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017)
Patient Problem Insufficient Information (4580)
Event Date 06/29/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_prog, serial#: unknown, product type: programmer, physician. Product id: 8781, lot#: 0219777631, implanted: (b)(6) 2021, product type: catheter. Other relevant device(s) are: product id: neu_unknown_prog, serial/lot #: unknown. 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 distributor regarding a patient who was receiving gabalon (250 mcg/ml at 50 mcg/day) via an implantable infusion pump for spastic paraplegia. It was reported overdose occurred on (b)(6) 2021. A refill was performed at 11:30 on (b)(6) 2021. The drug/infusion settings were to be changed from 250 mcg/ml and 50 mcg/day to 500 mcg/ml and 60 mcg/day. It was stated, "at this time, input to the programmer. 50mcg of the drug in the catheter /day was mistaken by 250 mcg. " at 14:30 (3 hours after the start of the administration), programming was performed again. During this period, 31 mcg had been administered, resulting in an overdose. From 14:30 to 16:30, the patient commented, "when he/she heard that a high concentration was being administered, it was felt a little dull, but there was no particular change. " it was stated, "at the time of attending the case , the programming error was not noticed and the drug was overdose. Since then, no side effects have been seen at this time. " the event was considered not serious. The outcome of the adverse event was unknown. The event was considered causally related to the drug, and not causally related to the catheter, pump, programmer, or surgical procedure. Further complications were not reported. Additional information was received. At 18:30 on (b)(6) 2021, the patient was being monitored without any adverse event. It was stated the patient would be at home on (b)(6) 2021, "so there will be no problem. ".
 
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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 Key12186211
MDR Text Key262203088
Report Number3004209178-2021-11005
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/16/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured09/08/2020
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: 07/17/2021 Patient Sequence Number: 1
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