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

Model Number 8637-40

Device Problems Filling Problem (1233); Migration or Expulsion of Device (1395); Communication or Transmission Problem (2896)

Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Seroma (2069); Post Operative Wound Infection (2446)

Event Date 03/05/2021

Event Type  Injury  

Event Description

Information was received from a consumer regarding a patient receiving morphine via an implanted pump.The indication for pump use was chronic low back pain and spinal pain.The patient reported that he went in for his first pump refill a few days ago and the nurse was unable to fill the pump due to some fluid around the pocket of the pump.When the nurse put a needle in the pump for the refill, it was oozing fluid that the patient thought was blood, but the nurse said it was fluid around the pump.The fluid had been present since the pump was implanted and it also made it difficult for him to use his ptm (personal therapy manager).The screen would often say ¿pump not responding¿.Per the patient, he had a cat scan for the issue.Additional information was received on 07-jan-2022 from a healthcare provider (hcp) who reported that they were not certain that the fluid around the pump was the reason for the difficulty refilling the pump.The hcp believed the latter was more likely a technical issue.Another provider attempted a pump refill within 1 to 3 months prior to the visit with the reporting hcp.Per the hcp, the fluid may be post-surgical.They were going to screen for any possible infectious causes and were planning exploration of the patient¿s pump and intrathecal catheter.

Manufacturer Narrative

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

(b)(6) 2022 (b)(6) and follow up (rep, hcp) additional information was received that the healthcare provider (hcp) reported that the patient went to the hospital concerned about a postoperative wound infection.The patient presented with erythema and inflammation about the pump site.The hcp was considering the possibility that this may be an abscess.The hcp was contacting the emergency room (er) physician asking him to aspirate the pump pocket.The patient will be admitted with iv antibiotics.The hcp will see the patient in-house and consider further action.The issue was not resolved at the time of this report.Patient factors that may have led or contributed to the issue were obesity and diabetes.The patient's weight and medical history were asked but would not be made available.The patient was reported alive with no injury.Additional information was received that the er doc aspirated it and it looked serosanguinous.The patient apparently wanted the pump out.The hcp advised that if it was not infected, they would not take it out emergently.They would be seeing them in clinic to discuss it.(b)(6) 2022 e1 (rep) additional information was received that the wound was aspirated and the aspirate was sterile.The patient was discharged to home with the diagnosis of a seroma.The device remains implanted and is still in use.There is no plan for follow up specific to this encounter.The patient will follow up at regular intervals consistent with the care of any newly implanted patient.

Event Description

Additional information was received from a company representative (rep).It was reported that the patient was having problems connecting his communicator / ptm to his pump.The rep stated that the patient had to charge his handset every day.The rep stated the patient was using the new handset and wanted to review if the 8835 would be any different.The rep stated that two months after implant the patient had a seroma and believed that the communication could be related to the seroma a flip pump that could be causing all these issues.The seromas had been a reoccurring issue and the patient was supposed to see the managing healthcare provider the morning of 2022-sep-15 to see if they could communicate with the pump with a samsung tablet.The patient did not show and they would have to reschedule for further appointment.No symptoms were reported.

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 healthcare provider (hcp) via the company representative who reported that the patient was a no call/no show with his managing physician for appointments both last friday and yesterday.As such, no additional diagnostics could be performed.No causative factor could be identified.The physician was aware.The physician intends to allow this patient to call the office to reschedule when it¿s enough of a priority for him to do so; as such, no additional follow up was scheduled.

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 on 24-oct-2022 that reported the patient was taken to the operating room today for exploration of the pump pocket.The patient previously reported pain and that the ¿pump was flipping¿ to a physician at a local va clinic.That physician referred the patient to a neurosurgeon without informing the managing pain physician.Upon incision, the surgeon encountered pus.He aspirated the pus and sent to lab for cultures.The surgeon explanted the entire system.He commented that previous labs indicated a normal crp/esr/wbc.The patient would be prescribed antibiotics and eventually referred back to the managing healthcare provider for pain management.The managing physician stated he does not believe he will offer the patient a new pump because of the psychiatric issues that became apparent during treatment following placement of the first pump.

• 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: 13235038
• MDR Text Key: 283662805
• Report Number: 3004209178-2022-00517
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2022
• Date Device Manufactured: 02/02/2021
• 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; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 171 KG