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 Headache (1880); Pain (1994); Diaphoresis (2452); Insufficient Information (4580)

Event Date 01/18/2022

Event Type  Injury  

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, foreign) regarding a patient who w as receiving an unknown drug of an unknown concentration at an unknown dose rate via an implantable pump.It was initially reported on (b)(6) 2022 that the patient experienced withdrawal symptoms.Environmental/external/patient factors that may have led or contributed to the issue were unknown.The pump remained filled with medication.The pump remained implanted / in-service.No further actions were taken at this point to resolve the issue.No surgical intervention occurred and it was unknown if surgical intervention was planned.The issue was not resolved as of (b)(6) 2022.Further exploration was requested on the pump in collaboration with technical support.The patient's medical history, gender, age, and weight at the time of the event were unknown or would not be made available.Additional information was received from a foreign healthcare provider via a company representative on (b)(6) 2022.The pump was implanted in (b)(6) 2021.The date (b)(6) 2021 is considered an approximate date of implant (specific month and year known only).The patient had experienced more pain, headache, and sweating.During the last two refills there was more drug in the pump then indicated.The logs were read on 2022-jan-21.There was no indications of problems with the pump in the logs.The pain physician was to discuss with the neurosurgeon what actions would be taken to resolve the event.The issue was not yet resolved.The device remained implanted.

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, lot#: unknown, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id 8731 lot# unknown serial# implanted: explanted: product type catheter 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 a foreign healthcare provider via a manufacturer's representative on (b)(6) 2022.It was reported that a catheter issue was suspected, but a catheter study was performed and no obstructions were found at that time.The cause of the volume discrepancies was not determined.The resolution of the event would be determined following the pump replacement.The pump was replaced on (b)(6) 2022.

Event Description

Additional information was received from a foreign healthcare provider via a manufacturer's representative on (b)(6) 2022.It was confirmed that the catheter was not replaced when the pump was replaced.

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

B2 correction: intervention required was not previously checked in error.H1 correction: the type of report was not previously updated from initially being a reportable malfunction to now a reportable serious injury.H6 correction: the annex code f1905 and f12 were not previously applied in error.The previously applied annex code f11 is no longer applicable.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: 13358561
• MDR Text Key: 290458697
• Report Number: 3004209178-2022-01207
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 03/01/2022; 03/14/2022; 07/20/2022
• Supplement Dates FDA Received: 03/03/2022; 03/16/2022; 07/20/2022
• Date Device Manufactured: 01/17/2020
• 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
• Treatment: SEE H10....
• Patient Outcome(s): Required Intervention