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

Model Number 8637-40

Device Problem Insufficient Information (3190)

Patient Problems Itching Sensation (1943); Pain (1994); Loss of Range of Motion (2032); Twitching (2172); Chills (2191); Discomfort (2330); Diaphoresis (2452); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Cognitive Changes (2551); Weight Changes (2607); Alteration in Body Temperature (4568); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient receiving dilaudid via an implanted infusion pump.It was reported the patient had jerky movements after therapy and steps were hard when moving.There was concern with poisoning from the battery.The patient was achy, had restrictive movement, and was hallucinating.It was mentioned the patient was maybe not taking medication.Additional information received from a consumer reported the patient had withdrawal symptoms including itching, sweating, having chills, pain, issues walking, hot and cold, magnets pulling on her feet and no sleep.Troubleshooting was unable to be performed and the patient was redirected to their healthcare provider to further address the issue.

Event Description

Additional information was received from the patient who reported that she received a new ptm (personal therapy manager) a month or two ago and then started feeling "a pulling" in certain directions, like gravity.She stated that her "boobs are pulling downward." per the patient, her pump was implanted in her stomach.She stated didn't have issues before, but now she weighs less.The patient then asked if lotions and perfumes were okay to use; if she should worry about fire; and if the pump could have any effect on her feet and her alkaline phosphatase.She also stated that she had previous cat scans, mri, and x-rays.

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.

• 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
• MDR Report Key: 11733762
• MDR Text Key: 247569257
• Report Number: 3004209178-2021-06774
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other