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

Model Number 8637-20

Device Problems Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Fatigue (1849); Rash (2033); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving bupivacaine (5 mg/ml at 1.99875 mg/day), clonidine (100 mcg/ml at 39.975 mcg/day), and morphine (20 mg/ml at 7.995 mg/day) via an implanted pump.The indication for pump use was spinal pain.It was reported that the patient¿s pump was malfunctioning.Per the hcp, the patient came in for a refill on (b)(6) 2021 stating that she ¿wasn¿t feeling right¿.They then filled her pump and she began to have a ¿systemic reaction¿ and had a rash near the pump site in the soft tissues.The hcp sent her home and the patient stated that last night she felt drugged, was falling asleep, and was barely able to stay awake.The hcp brought her back in today and took out the medication and put contrast in and realized that the contrast was ¿spraying out of the port¿.The ¿connector port¿ was leaking and he believed that the pump was ¿throwing a bolus by itself¿ and stated that he did not have flex/boluses programmed.The shutdown code to permanently stop the pump was requested and provided during the call.

Manufacturer Narrative

Continuation of d10: product id 8709 serial# (b)(6) implanted: 2003-(b)(6) explanted: 2021-(b)(6) product type catheter product id 8709 lot# serial# (b)(6) implanted: 2003-(b)(6) explanted: 2021-07-02 product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8709, serial#: (b)(6) 3, ubd: 2005-02-20, 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 via a company representative.The patient¿s medical history included chronic pain syndrome and lumbar post laminectomy.It was noted that there was a problem post refill, and the pump was shut down.It was indicated that the patient was told something was wrong with the pump and catheter.The company representative had asked the patient what was wrong, but the patient could not provide any meaningful details.The date of the event was 2021-(b)(6) (previously reported as 2021-(b)(6)).Regarding environmental/external/patient factors that may have led or contributed to the issue, it was noted that there were none.The pump and catheter were replaced on 2021-(b)(6).It was further noted that the catheter was partially explanted.A majority of the catheter remained implanted but inactive; was tied off in the pump pocket.The issue was resolved.The patient was without injury regarding their status as of 2021-(b)(6).The company representative was in possession of the explanted product w hich was to be returned to the manufacturer.

Event Description

Additional information was received from the device manufacturer representative indicated that the 8780 was dislodged during tunneling.It was reported that the doctor had to implant a second 8780 after removing the first one entirely.

Manufacturer Narrative

Concomitant medical products: product id 8709 serial# (b)(6) implanted:(b)(6) 2003.Explanted: (b)(6) 2021 product type catheter product id 8709 serial#(b)(6) implanted: (b)(6) 2003.Explanted: (b)(6) 2021.Product type catheter product id 8780 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.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 pump was analyzed and exceeded the dispense accuracy specification by dispensing more fluid than the programmed rate.The ca theter was returned and no significant anomalies were identified.Continuation of d10: product id 8709 lot# (b)(6) implanted: (b)(6) 2003 explanted: (b)(6) 2021 product type catheter product id 8709 lot# (b)(6) implanted: (b)(6) 2003 explanted: (b)(6) 2021 product type catheter product id 8780 lot# serial# unknown 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.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
• MDR Report Key: 11875107
• MDR Text Key: 265901473
• Report Number: 3004209178-2021-08243
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; "SEE H10...."; SEE H10....
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR