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); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Difficult to Advance (2920); Infusion or Flow Problem (2964)

Patient Problems Muscular Rigidity (1968); Therapeutic Effects, Unexpected (2099)

Event Date 08/12/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(4), product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 18-may-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a company representative regarding a patient receiving an unknown medication via an implanted pump.The indication for pump use was intractable spasticity.It was reported that approximately 2 weeks post implant, the patient had increased spasticity and the pump started beeping on (b)(6) 2019.The patient was not experiencing any signs of withdrawal.With regards to any environmental, external, or patient factors that may have led or contributed to the issue, ¿n/a¿ was noted.The patient had a dye study approximately 1 month ago where an obstruction of dye was found.The catheter was occluded.The patient was to follow-up with his pump managing physician on (b)(6) 2019 about the pump alarm and was instructed to go to the emergency room if withdrawal symptoms occurred.The patient was also to see a neurosurgeon to have a surgical consult for the catheter issue.The issues were not resolved at the time of this report.The patient status was reported as ¿alive ¿ no injury¿.No further complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received on (b)(6) 2020 at which time it was reported that the cause for the empty pump was that they had chosen not to refill the pump pending the catheter revision and the plan was to refill the pump at that time.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received on 02-jan-2020 from a healthcare professional (hcp) via a company representative who reported that the patient was scheduled for a catheter replacement on (b)(6) 2020 and the pump would be refilled at that time if needed, but the patient¿s family then declined the surgery at this time because they were moving.The physician did not consider the case to be urgent based on the family¿s response.Per the hcp, they would potentially reschedule but no further follow-up by the physician¿s office was planned at this time.The case was considered closed and additional details would be provided when/if they became available.No further complications have been reported as a result of this event.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 16-mar-2020 at which time it was reported that the surgeon believed that the catheter was probably always epidural as he worked for over 2 hours during the first case and never got csf (cerebrospinal fluid) return.During the revision, after multiple attempts, he was still not successful in getting csf return.He then made the decision to do a laminectomy and successfully placed the new catheter in the epidural space via direct visualization.No further complications were reported/anticipated.

Event Description

Additional information was received from a healthcare professional (hcp).It was reported that the hcp was unable to aspirate from the catheter access port at the dye study.No volume discrepancies were seen.The alarm being heard was for a low reservoir volume which occurred on (b)(6) 2019 and had since gone empty.No further complications were reported.

Manufacturer Narrative

Continuation of d11: product id 8780 lot# serial# (b)(6) implanted: (b)(6) 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.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 (b)(6), additional information was received from the healthcare professional (hcp) via a manufacturer representative (rep).It was reported the catheter was replaced on (b)(6),.The surgeon suspected the catheter was epidural.Th patient was not getting relief of spasticity and no cerebrospinal fluid (csf) could be aspirated.The surgeon stated that they had an unusually difficult time placing it in the original procedure.The catheter was successfully replaced via laminectomy.The issue was resolved at the time of this report.The patient was receiving baclofen (2,000 mcg/ml, 280 mcg/day).The patient's status was alive - no injury.

Manufacturer Narrative

Continuation of d11: product id 8780 lot# serial# (b)(6) implanted: (b)(6) explanted: 2020-03-13 product type catheter h6; device codes have been updated to include c62917 and c63235.Patient codes have been updated to include c50789.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: 9509570
• MDR Text Key: 181384930
• Report Number: 3004209178-2019-24327
• 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,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Weight: 109