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

Model Number 8637-40

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Paralysis (1997); Numbness (2415)

Event Date 10/17/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8598a , serial# (b)(4), implanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: product id: 8598a, serial/lot #: (b)(4), ubd: 12-aug-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving unknown drug via an implantable pump.It was reported the patient called the hospital, on (b)(6) 2021, and noted their leg felt numbness/paralyzed after bolus and was unable to feel bolus to lower back.On (b)(6) 2021, a catheter access port (cap) contrast study was performed and showed the catheter had migrated from t7 to t11.Revision was set for (b)(6) 2021.The clinical diagnosis was inadequate pain relief.It was indicated the event was related to the device or therapy.The event was ongoing.

Event Description

Additional information received from a healthcare provider (hcp) via company representative (rep) reported that the patient was brought in on (b)(6) 2021 for a catheter revision and discovered that the catheter had migrated just before the anchor; however, the anchor was still intact.The hcp repaired the cerebrospinal fluid (csf) leak and removed the entire existing 8598a catheter.The hcp opened up a new 8598a catheter and put the new spinal segment up to t7.The hcp was getting excellent csf flow and connected this piece to the existing pump segment.No dosing changes were made.Of note, the patient denied falls or external issues.The issue was resolved at the time or report.The patient's status at the time of report was alive - no injury.

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

H3: the catheter was returned, and analysis found a hole in the catheter body caused by catheter connector pin.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: 12681183
• MDR Text Key: 277884315
• Report Number: 3004209178-2021-15748
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422615
• UDI-Public: 00763000422615
• 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: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2022

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: 01/28/2023
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 10/22/2021
• Supplement Dates Manufacturer Received: 11/04/2021; 02/01/2022
• Supplement Dates FDA Received: 11/08/2021; 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• 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): Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 108 KG