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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Tingling (2171); Therapeutic Response, Decreased (2271); Distress (2329); Complaint, Ill-Defined (2331); Cognitive Changes (2551); Confusion/ Disorientation (2553); No Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2020

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 via a company representative regarding a patient receiving lioresal 2,000 mcg/ml flex dose 383.8 mcg/day via an implantable pump.It was reported that the company representative was contacted by the hospital to interrogate the patient¿s pump.The pump logs were read, and the pump logs showed non-critical alarm (b)(6) 2020 at 3:58pm and critical alarm (b)(6) 2020 at 4:01 am.The environmental, external or patient factors that may have led or contribute to the issue was the patient¿s mother did not remember the pump refill date.The patient¿s managing physician refilled the patient¿s pump on tuesday (b)(6) 2020.The issue was resolved, and it was noted that the healthcare provider would not have any further information regarding the event.

Event Description

The rep reported that they were not aware of any symptoms related to the pump alarm and missed refill.The pump activity logs showed a non-critical and critical alarm occurred.

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.

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

Additional information was received from the patient¿s mother who reported that they did not hear the pump alarm when it was determined that the pump had run out of medication and the patient spent 3 days in the hospital with baclofen withdrawal.She stated that she, the patient, and her husband all did not hear the pump alarm at the time of the event, and 4-5 different people never heard the pump alarm go off.The doctor had since played the alarms so they could hear what the alarms sounded like, but they could not tell if it was the tablet or the pump sounding.They couldn¿t hear the alarm.The doctor played it 4-6 times before they could register it.She stated that what she found out was that when the doctor implanted the current pump, the pump was not filled all the way with medication and the dosing in the pump was changed so the pump ran out of medication.The doctor¿s office told them the clinic had been trying to call them to set up a refill date, but per the reporter, they never got a call or received any message.They noticed that the patient was having return of symptoms such as ¿radh¿, tingling, pricking like something was biting her, mental confus ion, staring, and her ¿personality went deep inside her¿.Per the reporter, the patient could not communicate well, and all of these were her distress signals.The patient thought she was going crazy and stated, ¿it was such a dark place and it was horrific¿.The patient¿s mother wanted to know if there was a way to turn up the volume on the pump alarm or if there was pump technology that could notify via an external device if the pump was alarming because it would be beneficial for caregivers and for hearing impaired people.Per the reporter, their physician suggested ordering a ptm (personal therapy manager).

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

Additional information was received from the consumer indicated that the patient purchased a a820 ptm.

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

After conversation with managing physician and staff, it was confirmed that at the patient¿s last refill appointment, the date of (b)(6) 2020 was provided as next refill appointment.Clinic staff confirmed that reminder messages were left on both mother and father¿s phone, as well as home phone.No-showed refill appointment, which led to withdrawal.Within text message content, patient¿s mother mentioned calling the manufacturer and asked about ptm and she needed to get a device to determine if alarm has occurred on the pump.She discussed with the doctor her desire to obtain a ptm device.In follow-up with the doctor, she acknowledged ptm is off label use for itb therapy, she will plan to discuss with patient¿s mother regarding obtaining ptm device.

• 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: 10585625
• MDR Text Key: 208500608
• Report Number: 3004209178-2020-16678
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 27 YR