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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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MEDTRONIC NEUROMODULATION SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637
Device Problems Improper or Incorrect Procedure or Method (2017); Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/18/2022
Event Type  malfunction  
Event Description
Information was received from multiple sources (manufacturer representative (rep), healthcare provider (hcp)) regarding a patient who was receiving unknown drug via an implantable pump for unknown indications for use. It was reported that the hcp saw service code 144. Technical services reviewed the meaning of code as "pump memory error. Invalid pump clock time". It was unknown if the message was seen before or after the update. The hcp thought they updated the pump successfully; however, while in the middle of the first update the batteries died so they had to switch to a different clinician programmer. The rep reported that they assumed the hcp was using the 8840 for initial programming and then those batteries died so they switched to a clinician tablet. Technical services reviewed that this could explain the reason for the code. The rep later reported that the patient was back in the office on (b)(6) 2022 reporting that their pump was not working. The rep reported that the hcp was now seeing service code 140. Technical services review ed meaning of 140 service code as previous update failed and to have hcp check logs and reprogram pump with appropriate settings.
 
Manufacturer Narrative
Concomitant medical product: product id: a810. 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 NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central ave ne
minneapolis MN 55432
Manufacturer Contact
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key13592362
MDR Text Key286471815
Report Number2182207-2022-00330
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,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637
Device Catalogue Number8637
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/21/2022
Was Device Evaluated by Manufacturer? No Answer Provided
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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