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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423); Aspiration Issue (2883); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), (b)(6), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2018, information was received from an healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient receiving gablofen (2,000 mcg/ml, unknown dose) via an implantable pump for cerebral palsy and intractable spasticity.Beginning on an unknown date, the patient was not getting the expected relief from the pump despite dose titrations.A dye study was attempted on an unknown date, but they were unable to aspirate.The catheter was surgically revised on (b)(6) 2018.During revision, shearing of the catheter near the pump connector was present.Approximately 2 cm of the outer layer of the catheter had separated from the internal layers.After the spinal segment of the catheter was explanted, the hcp attempted to inject saline through it and only one of the fluid outlet holes was patent.The event was resolved at the time of this report.The patient¿s status was alive ¿ no injury.

Manufacturer Narrative

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

Event Description

On 2018-june-06, additional information was received from a manufacturer representative (rep).It reported the cause of the shearing of the catheter has not been determined.It was unknown if the patient was receiving relief now.The cause of the fluid outlet hole blockage was unknown.The pump was set to minimum rate (13.5 mcg/day).

Manufacturer Narrative

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

Event Description

On 2018-june-07, additional information received from the rep indicated that the previously reported information had been confirmed with the healthcare professional (hcp) on (b)(6) 2018.

Manufacturer Narrative

Concomitant medical products: product id 8780 serial# (b)(4).Implanted: (b)(6) 2017, explanted: (b)(6) 2018.Product type catheter device evaluated by mfr: analysis of the catheter (serial number (b)(4).Found damage to the transition tube.Visual inspection identified there was damage to the transition tubing.The catheter was returned in segments and no leaks were identified.Initial patency testing found the catheter to be occluded.The occlusion broke loose during the decontamination process and passed subsequent patency testing.The conclusion code 92 no longer applies to this event and was updated to 4315; due to imdrf harmonization, the previously reported device codes c62896 and c63299 no longer apply to this event.The device codes have been updated to include c63075 and c62897.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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: 7569589
• MDR Text Key: 110095059
• Report Number: 3004209178-2018-12599
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,Followup
• Report Date: 08/22/2018

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: 06/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 06/06/2018; 06/04/2018; 08/17/2018
• Supplement Dates FDA Received: 06/07/2018; 06/08/2018; 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 28