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

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Twiddlers Syndrome (2114); No Known Impact Or Consequence To Patient (2692); Twiddlers Syndrome (4563); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, lot/serial#: (b)(4), implanted: (b)(6) 2020 product type: catheter, ubd: 16-oct-2021, udi#: (b)(4).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 manufacturing representative (rep) regarding a patient receiving 2 mg/ml of morphine at 0.096 mg/day via an implantable pump.It was reported the patient was scheduled for a pocket revision due to a flipped pump.It was noted the 40 ml pump was also replaced with a 20 ml pump due to refill intervals.During the procedure, the catheter was noticed to be cut and very twisted in the pump pocket.The catheter was explored in the spine as well and it was noticed the catheter was pulled from spine and no longer in the intrathecal space.It appeared as though the sutures holding the anchor failed.The entire catheter was removed and replaced and a new 20 ml pump was implanted, resolving the reported issue.It was unknown if there were any environmental/external/patient factors that may have led or contributed to the reported event.

Manufacturer Narrative

Continuation of d11: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2020 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

On 2020-oct-21, additional information was received from the manufacturer representative (rep).The cause of the pump flipping was n ot determined, but suspected to be due to patient manipulation.The cut in the catheter was "likely broken due to manipulation of the pump.Return of the catheter was expected.

Manufacturer Narrative

Continuation of d10: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 2020 explanted: product type catheter h3: evaluation of implantable pump serial number (b)(6) revealed no anomalies.The returned pump passed all functional testing in the lab.Evaluation of implantable catheter serial number (b)(6) found significant twisting along the catheter and multiple kinks.Analysis also identified compressed areas deformed in shape.One compressed area was consistent with a removed/missing suture tie.Analysis also identified damage to the transition tubing.H6: the evaluation codes have been updated for this event.Code result c19 only applies to the pump.Code conclusion d14 applies to the pump and code conclusion d12 applies to the 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.

• 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: 10707831
• MDR Text Key: 212469342
• Report Number: 3004209178-2020-18344
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Date Manufacturer Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR
• Patient Weight: 129