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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Pain (1994); Scar Tissue (2060); Insufficient Information (4580)

Event Type  Injury  

Event Description

Information was received from a patient who was receiving an unknown drug via an implantable pump for unknown indications for use.It was reported that patient stated they read an article on the same pump model that detailed the same malfunction of their previous pump that was placed in (b)(6) 2020.They stated that the medtronic technician kept claiming it was the catheter malfunctioning but when the healthcare provider replaced the non-functional pump and the catheter in (b)(6) 2021, it was found that there was nothing wrong with the catheter.They went through agony and suffering for over 10 months with that pump and then found out that mdt was aware of the problem with this model of pump but they were never told about this issue.

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 8709 lot# j0039937r serial# implanted: (b)(6)2000 explanted: (b)(6)2021 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(6) , ubd: 2002-07-17 , udi#: (b)(6) 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 consumer (con) regarding a patient receiving dilaudid (unknown dose and concentration) and two other unknown drugs via an implantable infusion pump.The indication for use was non-malignant pain.It was reported that the patient had her pump replaced and shortly after, her pain escalated.The patient stated that yesterday she looked online and saw that there was a recall for an foreign particle field action and that was exactly what happened to her in 2021.Patient services reviewed with the patient that her pump was not part of that field action.The patient did not know if her pump had stalled or not, or the cause of her therapy.The patient stated that the physician talked to the manufacturer's representative (rep) and the rep was present at the dye study but the rep never told her that there was a recall.The patient stated that normally her pain was between 3-4 and all of the sudden on (b)(6), her pain jumped to a 5.The patient stated that she started seeing a new physician in (b)(6) and she told him the pain was higher.The patient stated that she never heard a pump alarm and she doesn't remember her physician ever mentioning that the pump alarmed or if logs were ever checked.The patient stated that by march her pain was at an 8.In april she went for a dye study, but they were unable to aspirate so the physician filled it again in may and the re were 10 extra ml's in the reservoir.The healthcare professional (hcp) filled it one more time in (b)(6) and there were 35ml in the reservoir when there should have been 8ml.The patient stated that the surgeon ordered a magnetic resonance imaging (mri) scan to rule out a granuloma, but none was found and no issues with the catheter were seen.The patient stated that they replaced the entire system and there was scar tissue so when they moved the catheter, it broke.The patient stated that the hcp examined all the catheter and did not find any issues at the surgery.The patient stated that her previous pump always gave her 0.5mg /day extra because it always had 4ml less in the reservoir but the hcp knew how to program the pump accordingly.The patient stated that they shut her pump down once and she was in major withdrawal, so she knows what that feels like and she did not have withdrawal.The patient stated that by july the pump wasn't working at all so the hcp called technical services and programmed the pump to minimum rate mode.The patient stated that there were 2 other drugs with the dilaudid.

Event Description

Additional information received from a healthcare provider reported that the issues reported occurred before the physician took over the patients care, but have had no further issues since.

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: 16520590
• MDR Text Key: 311042717
• Report Number: 3004209178-2023-03285
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2023
• Date Device Manufactured: 10/07/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female