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

Model Number	8637-20
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received from a consumer regarding a patient previously receiving intrathecal hydromorphone and bupivacaine (concentrations and doses unknown) via an implanted pump for non-malignant pain.It was reported the patient and the healthcare provider (hcp) made the decision to abandon therapy as the hcp no longer implants pumps.It was noted last (b)(6), the hcp removed mediation from pump and put in saline.The patient went through withdrawal.The patient was told the pump would "signal in august" and patient asked what that meant.Pss reviewed eri and eos/alarms and considerations.The patient planned to leave the pump implanted and asked if that would harm the patient.The patient inquired how to silence the alarm.The patient asked if they choose to leave the alarm going would that harm the patient.It was noted the pump was implanted for peripheral neuropathy and the hcp was going to try and pursue pills, but gabapentin didn't work.Additional information was received from a consumer on(b)(6)2022 and the patient was told the alarm would start to sound on (b)(6)2022.The patient asked how to silence the alarm so it did not bother the patient¿s ill husband.Additional information was received from a consumer and it was reported 'about 2 years in(b)(6), the hospital could no longer supply the hydromorphine (later confirmed they also had bupivacaine in the pump with the hydromorphine) because they couldn't make it.It was noted they turned the pump off in(b)(6) 2022.When we had it turned off, they took the old medicine out and put saline in it.The patient was told that when the saline ran out, it would beep until the batteries went dead.It was reported, ¿i'm a little surprised because it's going to be 2 years and i don't have any idea when the batteries will run out because it still makes a european alarm every few hours.¿ while on the call, the patient mentioned ¿this was my second pump in 13 years.I've had them working for 13 years.When they worked, they worked perfectly.Now, it will be 2 years in (b)(6) with this music (pump alarming) going on.I had gallbladder stones and they removed them, but i still amuncomfortable.I didn't know if the batteries (from the pump) would ever leak.¿ patient stated, ¿i'm going on 79 and i'm on a walker.The only way i could get to doctor¿s office, the person who put it in.But, he no longer does it.After we turned it off, the saline was gone and it was beeping.I called him 4 times and they said i'm not a patient anymore and they don't return my calls.¿ it was reported the patient thought ¿i'd just live with it thinking the battery would run out in a month or two.But i'm having those internal problems so i wanted to check.¿ agent reviewed pump longevity and alarm considerations.Agent unable to determine alarm date(s) due to nature of call and the patient not providing timeline when asked.Patient inquired about having the pump explanted.Agent redirected patient to healthcare provider to discuss explant options.Agent sent physician listings mail request and emailed the field for visibility.Additional information was from a consumer (con) stated that the patient mentioned that the pump moved quite some time ago.The patient stated that it was under her left rib, and it moved down.The patient thought it was because she does not stand straight.She was bent almost 90 degrees and has been in car accidents.The pump was still alarming.The patient reviewed explant options.The patient services (pss) sent hcp listings via mail.Additional information was received from a consumer (con) stated that about two years ago, in (b)(6) 2022, the patient weight 108 pounds.Since, then, they gain weight, particularly around the midsection, and their pump dropped.The pump battery still goes off all the time.The patient reached out to medtronic and still waiting for a response.It was reported that the anchors had come lose on their spine.No surgical intervention was performed to address the pump movement.The patient had two pumps working for thirteen years but stop using them because ¿the proper medicine was not long able.¿.
Additional Manufacturer Narrative
Continuation of d10: product id neu_unknown_cath lot# serial# unknown implanted: explanted: product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown, ubd: , udi#:.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: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112-4391 ; 7635269277
• MDR Report Key: 20760074
• Report Number: 3004209178-2024-22522
• Device Sequence Number: 12929499
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2024

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: 07/14/2017
• 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: 11/15/2024
• Initial Report FDA Received Date: 11/22/2024
• Date Device Manufactured: 01/18/2016
• 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: 76 YR
• Patient Sex: Female