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

Model Number	8637-40
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Information was received from a patient who was receiving dilaudid (hydromorphone) via an implantable pump for non-malignant pain indications for use.It was reported that their pump quit working due to reaching end of service, and they were in the process of trying to get a pump replacement.The patient stated that they have an appointment on the 23rd with a new doctor that they have never met.The patient stated they wanted to have the pump filled last month and there was nothing in the pump.The patient claimed that there was no alarm that went off.The patient stated that they were using oxycodone oral meds in place of the dilaudid that was in the pump while they coordinate the replacement of the pump.The agent reviewed the pump longevity and redirected the patient to a healthcare provider to further address the issue.The patient stated they were working on coordinating with ¿(b)(6) to have the pump replaced.
Additional Manufacturer Narrative
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.
Event or Problem Description
Additional information received from the patient indicated that, in regards to if there was a device, patient/therapy or procedural issue related to the empty pump, it was "undetermined insignificants, 'negligence'".The patient stated that "if whomever reads the pump must have a level of knowledge to inform the doctor and staff of the pump shut off and alarm, up to the minute must be documented, it is imperative¿.Life in jeopardy".The cause of the empty pump was not determined; "u.I., not sure/product liability" was reported.The patient also stated that, in regards to the cause of the empty pump, "one could speculate, however supervisors and doctors are solely responsible¿.The techs need to have a degree of some nature.'prc' must employ only qualified individuals.A trained tech could be sufficient, if a class was taken".In regards to steps taken to resolve the empty pump, "u.I." was reported; the patient's pump and catheter remained in his body.The empty pump did not resolve; the pump remained intact on the patient's left hip under the skin.The event would hopefully be resolved in december.The patient inquired " how many parts in a pump, the large one".

• 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: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 22707270
• Report Number: 3004209178-2025-13168
• Device Sequence Number: 9502286
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: (01)00643169530126(17)190914
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 12/01/2025
• Date Device Manufactured: 03/27/2018
• 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
• Patient Age: 74 YR
• Patient Sex: Male