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

Model Number 8637-20

Device Problem Failure to Interrogate (1332)

Patient Problem Pain (1994)

Event Date 04/26/2021

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 foreign healthcare provider (hcp) via a manufacturer's representative (rep) regarding a patient who was receiving baclofen and morphine via an implantable pump for benign chronic pain (fbss).On (b)(6) 2021, it was reported that it was not possible to communicate with the pump during a refill and the refill did not actually take place.The hcp and rep tried with two different n'vision programmers, with a tablet, and rooms were changed to exclude any electromagnetic interference (emi).It was possible to clearly identify by touch the silicone septum where the needle was normally inserted to make the refill so the pump did not flip in the pocket.It was unknown what, if any, environmental/external/patient factors that might have led or contributed to the issue.No appearance of withdrawal signs in the patient but simple exacerbation of painful symptoms.Eri was planned for pump in 2023, the pump was originally replaced in 2016.It was determined that it would be better to replace the pump and withdraw it for analysis.The planned surgery date was (b)(6) 2021.The issue was not considered resolved at the time of the report.The patient's status was listed as "alive - no injury".Additional information was received from a foreign healthcare provider (hcp) via a manufacturer's representative (rep) on 2021-may-12.It was reported that the pump was replaced as planned without any complications on (b)(6) 2021.

Manufacturer Narrative

H3: the returned device was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing.Telemetry of the pump failed.Destructive analysis of the battery revealed that the anode insulation system was breached, creating an internal short condition.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.

• 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: 11822350
• MDR Text Key: 251290012
• Report Number: 3004209178-2021-07700
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 11/10/2021

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: 09/14/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 09/22/2021; 11/10/2021
• Supplement Dates FDA Received: 10/18/2021; 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2016
• 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): Required Intervention