MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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. ".

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, 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 Key: 12186211
• MDR Text Key: 262203088
• Report Number: 3004209178-2021-11005
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• 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 Received: 07/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/28/2022
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• 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 Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 09/08/2020
• 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