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

Model Number	8637-20
Medical Device Problem Codes	Application Program Problem (2880); Insufficient Device Problem Information (3190); Data Problem (3196)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received from a patient who was receiving therapy via an implantable pump for unknown indications for use.It was reported that the patient was in the hospital and "they must have done something to my pump" because "it's not delivering my medicine".It was stated that the next refill date on pump report kept going further and further out despite the patient using all their boluses.The caller stated that after initiating a bolus the screen indicates it started but they also get "an error" so the patient knew they weren't actually getting a bolus.It was noted that the communicator was "separating down the middle", the caller was unable to confirm the wording of the error or recreate it during the call.It was noted that the patient uses their boluses to be able to eat and that they were experiencing a lot of pain.
Additional Manufacturer Narrative
Concomitant products: product id: tm90t0, serial#: unknown, product type: accessory.Other relevant device(s) are: product id: tm90t0, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
A correction was made to this field.Continuation of d10: product id tm90t0 ,serial# unknown, product type accessory.Product id a810 , product type software.Product id a820 , product type software.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SYNCHROMED II
• Common Device Name: 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13358584
• Report Number: 3004209178-2022-01208
• Device Sequence Number: 11178295
• Product Code: LKK
• UDI-Device Identifier: 00643169984219
• UDI-Public: 00643169984219
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 03/21/2024
• Date Device Manufactured: 08/07/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H10...."; "SEE H11...."
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Female