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

Model Number 8637-20

Device Problem Pumping Stopped (1503)

Patient Problems Pain (1994); Malaise (2359); Sleep Dysfunction (2517); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (patient, manufacturer representative, healthcare provider) regarding a patient who was receiving dilaudid (hydromorphone) (unknown concentration at 1.7 mg/day) via an implantable pump for unknown indications for use.Omitted information pertaining to infection and csf leak/infection/mrsa in (b)(4) and infection in (b)(4).It was reported that "since thanksgiving" the patient's pump has been in a motor stall and alarming intermittently.The patient reported being very sick with withdrawal symptoms and had not been able to sleep due to the pump alarming for the past 4 days and suffering for the last week, sick and in pain.The patient stated that they went to the physician and they turned off the alarm, turned off the patient's ability to bolus, reduced the medication by 30%, and provided the patient with oral medication.The patient denied recent mri (magnetic imaging resonance).Logs were read by the clinician which noted multiple motor stalls and recoveries indicated in logs.The patient will have their pump replaced in 2023.The surgery date has not been scheduled.The issue was not resolved at the time of report.The patient's weight and medical history were asked and will not be made available.The patient's status at the time of report was listed as "alive - no injury".The patient additionally wanted to check on any type of recall.The patient noted that they saw that their pump was on a recall.Patient services reviewed recall and reviewed that if the pump was included in a recall, a letter of notification would be sent to the managing physician.Patient services ran the patient's pump serial number to check if the serial number was included in the small particle recall.The response was "the serial number you entered is not included in the synchromed ii implantable infusion recall notification".

• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15902024
• MDR Text Key: 304685505
• Report Number: 3004209178-2022-15815
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2022
• Date Device Manufactured: 05/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female