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

Model Number 8637-20

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Pain (1994); Sleep Dysfunction (2517); Syncope/Fainting (4411); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 03/01/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiv ing an unknown drug via an implantable pump for spinal pain.It was reported that the patient had been extremely difficult to work with and all the healthcare provider's (hcp) had fired them from their practice.The patient's pump had gone empty for a week or more (the company representative (rep) had been given different dates so they couldn't confirm when it occurred).Last night the patient went to the emergency room (er) in desperation to have their pump refilled.The rep was thinking about turning off the pump alarm since the patient noted they had not been able to sleep due to it alarming and had been very adamant about it being turned off.Rep wanted to know steps on how to turn off pump alarm if it was empty.Technical services reviewed steps on how to do so by programming a false volume in order to update pump and putting a note to document there was no volume in reservoir.The rep was not with the patient.The patient later called in to report that their hcp "suddenly without cause kicked me out of their practice".Their pump went empty and started alarming causing them to go through withdrawal and to be "living in hell since february 10th", and states they have increased pain and are "going crazy." they couldn't find a doctor in their area that could take them sooner than a month from now.Patient services offered hcp list but the patient declined stating they called all those hcp's.Patient services reviewed mdt vs hcp role.The patient was extremely escalated and emotional during call and stated they couldn't live like this.Patient services offered to bridge the patient with crisis center but they stated they didn't need to talk to someone about this they just needed someone to turn the pump off.The patient spoke with a rep who "said they had connections" of an hcp who could fill pump, but then stated "it wasn't true, they blatantly lied to me and gave me false hope".Patient services again reviewed mdt vs hcp role.

Event Description

Additional information was received from the patient who reported that the pump was alarming every 10 minutes keeping her awake at night.Per the patient, it took two times to get them to turn it off.She went through severe withdrawals and ended up fainting in her bathroom.She ended up with a black eye, a lump over her left eyebrow, and she split her chin open which required stitches.Her pump was still empty and would remain empty until at least august.She was in severe pain and unable to perform basic daily tasks and daily selfcare.

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

Upon further review, it was determined that this event was erroneously reported for serious injury when it originally should have been reported as a malfunction.A follow up report is being sent to clarify this.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
• 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: 14014500
• MDR Text Key: 289431318
• Report Number: 3004209178-2022-04267
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2017
• 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: 06/10/2022
• Date Device Manufactured: 10/28/2015
• 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): Hospitalization
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 55 KG