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

Model Number 8637-40

Device Problems Premature Elective Replacement Indicator (1483); Pumping Stopped (1503); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2018

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 500 mcg/ml; 170 mcg/day via an implantable pump.Indication for use was intractable spasticity and cerebral palsy.The date of the event was (b)(6) 2018.It was reported the pump stalled and recovered on (b)(6) 2018 then stalled again on (b)(6) 2018 with no recovery noted in the logs.The patient did not recently have magnetic resonance imaging (mri).It was confirmed there were no electromagnetic interference (emi) or magnetic sources were present.No symptoms were reported.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer and a healthcare professional (hcp) via a manufacturer representative.The logs show that the pump motor stalled on (b)(6) 2018 at 4:20 am and recovered at 2:57 pm the same day.The pump continued to alarm that day so the provider silenced the active audible alarm.When interrogated on 10/12/2018, however, early elective replacement indicator (eri) states 14 months and the pump had 34 ml of baclofen.The pump was replaced on (b)(6) 2018 due to an (eri) alarm.The issue was resolved.Patient status was alive - no injury.Patient weight and medical history were asked but unknown.The pump was delivering gablofen 500 mcg/ml;100 mcg/day.

Manufacturer Narrative

The pump was returned, and analysis found gear train anomaly, corrosion and-or wear and-or lubrication and stall due to shaft-bearing.The catheter was returned and analysis found sc connector/coring-tears-cuts in seal.Catheter body had damage to the transition tube.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2013, explanted: (b)(6) 2018, product type: catheter.Section 'device' information references the main component of the system.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 2015-02-01.(b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Continuation of d11: product id 8780, serial# (b)(4), product type catheter.Product id 8780, serial# (b)(4), product type catheter, udi# (b)(4).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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• MDR Report Key: 7907690
• MDR Text Key: 123534593
• Report Number: 3004209178-2018-21511
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Date Manufacturer Received: 01/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR