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

Model Number 8637-40

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Dyspnea (1816); Overdose (1988); Complaint, Ill-Defined (2331); Coma (2417); Cognitive Changes (2551)

Event Date 05/15/2019

Event Type  Injury  

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) regarding a patient who was receiving baclofen at unknown dose and concentration via intrathecal drug delivery pump.The indication for use was noted as intractable spasticity and cerebral palsy.It was reported that the hcp suspected a pocket fill occurred.The patient just came to the emergency room (er) post pump refill on (b)(6) 2019 and there was a suspected pocket fill.The hcp had limited history, but stated that the managing physician during the refill aspirated 20ml of fluid and filled the pump with 20ml of drug.The patient was obtunded with agonal breathing.The pump pocket was fluctuant and they aspirated 20ml of fluid from the pocket.There were no further complications reported at this time.

Event Description

Additional information was received on 28-oct-2019 from a consumer who reported that during the pump refill on (b)(6) 2019 the hcp (healthcare professional) missed the port and put the baclofen into the patient¿s abdomen.The patient experienced a baclofen overdose.The patient went into a coma and was in the hospital for 19 days.A physician decided that the pump should be replaced even though the pump was not malfunctioning.The pump was then replaced on (b)(6) 2019.The patient¿s medical history included cerebral palsy and a speech impediment.The pump was delivering baclofen at 400 mcg/day at the time of the event, and it was programmed to give more medication in the morning and less at night.No further complications were reported/anticipated.

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.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: 8618039
• MDR Text Key: 145348567
• Report Number: 3004209178-2019-09762
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1060-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 37 YR