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 Fatigue (1849); Pain (1994); Insufficient Information (4580)

Event Date 02/14/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: product id: 8835, serial#: (b)(4), product type: programmer, patient.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 a consumer (con) regarding a patient receiving bupivacaine (did not asked for the dosage/25 mg/ml) cloidine ( did not asked for the dosage/90 mg/ml) fentanyl(did not asked for the dosage/375 mg/ml) dilaudid (hydromorphone) (did not asked for the dosage/15 mg/ml).The indication use was for spinal pain.It was reported that the patient representative was unable to connect to the patient pump (b)(6) 2023 (this morning) and were getting service code 8476.They were redirected to their healthcare provider.The patient representative and the patient denied any magnetic resonance imaging (mri) recently or known electromagnetic interference (emi), but the patient representative stated the patient had a pump refill 'last week.' the patient stated that they heard their pump alarming on 2023-02-14, 'yesterday afternoon,' and 'maybe i'm in withdrawal' and the patient representative added 'she's having symptoms.' the patient representative stated the patient has oral dilaudid to take for 'break through pain' and the patient inquired if they should 4mg or more, and.The patient representative read from patient's pump refill sheet 'hydromorphone 15mg/ml, bupivacaine 25.0 mg/ml, clonidine 90.0 mg/ml, and fentanyl 375.0 mcg/ml.' the patient representative confirmed the hydromorphone is dilaudid.

Event Description

Additional information was received from the patient and their spouse who reported that the pump was turned to ¿neutral¿ and the patient was prescribed oral opioids.Per the patient their healthcare provider (hcp) ¿wants to do what sounded like an exploratory surgery but the pump was going to be replaced in 4 months anyway¿.The patient also stated that the hcp said they couldn¿t replace the pump for a month.During the call it was mentioned that the patient had "other medical issues", but they did not elaborate what those medical issues were.

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

Continuation of d10: product id: 8835, lot#serial#: (b)(6), product type: programmer, patient.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.

Event Description

Additional information received from the healthcare provider (hcp) via a company representative (rep) reported that the patient was seen in the hcp office on (b)(6) 2023 and the logs showed a motor stall occurred on (b)(6) 2023 at 3:18 pm and recovered the same day at 6:45 pm.The patient then was hospitalized for withdrawal and overdose symptoms.The patient had been drowsy as well.The pump was re-interrogated on (b)(6) 2023 at 4:27 pm and the logs showed that the pump had stalled again on (b)(6) 2023 at 4:07 am and recovered on (b)(6) 2023 at 8:54 am.The pump was put into minimum rate mode in case the pump stalled and recovered again.The event was not resolved at the time of the event.The patient was receiving bupivacaine (12.190 mg/day), clonidine (43.886 mcg/day), fentanyl (182.86 mcg/day), and dilaudid (7.314 mg/day).

• 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: 16418836
• MDR Text Key: 310064617
• Report Number: 3004209178-2023-02455
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2023
• Date Device Manufactured: 10/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Treatment: "SEE H10."
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female