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

Model Number 8637-20

Device Problems Kinked (1339); Obstruction of Flow (2423); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)

Event Type  Injury  

Manufacturer Narrative

Continuation of medical devices: product id 8782, serial# (b)(4), implanted: (b)(6) 2015, product type catheter.Product id 8780, serial# (b)(4), implanted: (b)(6) 2015, product type catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8782, serial/lot #: (b)(4), ubd: 30-may-2016, udi#: (b)(4); product id: 8780, serial/lot #: (b)(4), ubd: 16-dec-2016, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was provided by a healthcare provider via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver gablofen [3000 mcg/ml to 500 mcg/ml] at 819 mcg/day, indicated for intractable spasticity and cerebral palsy.It was reported that a difficulty occurred intra-operatively on (b)(6) 2018 during a intrathecal baclofen (itb) replacement case.It was reported that there was no cerebrospinal fluid (csf) back flow from the spinal segment of the catheter during an intrathecal baclofen replacement case.It was noted that existing catheter volume was 0.151 ml, and the 41.9 cm spinal segment "0.09218." the proximal piece of the catheter was attached to the pump and a back-table prime was done with the 500 mcg/ml of 0.306 mls.The existing spinal segment had 3000 mcg/ml.The caller was requesting calculations for the modified bridge bolus of the spinal segment.Technical services reviewed pertinent info per caller's inquires including programming, troubleshooted with caller and confirmed calculations per caller's request.It was noted that the rep would confer with the healthcare provider.No medical symptoms were reported.Additional information was received from a manufacturer's representative on (b)(6) 2018.It was clarified that the patient was brought in to replace the 20cc pump with a 40 cc pump, as the patient had moved and transportation to and from the refill clinic is challenging.It was reported that upon replacement, they were unable to aspirate the catheter, so a back table prime was performed (0.3 ml) in the operating room.It was reported that in pre-op, the mother of the patient stated that his efficacy had decreased and they suspected the catheter was "linked" or occluded.The surgeon attempted to introduce a new catheter; however, the patient has hardware from cervical spine to sacrum.Ultimately, they decided to just reconnect the existing catheter.The surgeon wanted to monitor the patient overnight.It was stated that the patient was discharged on saturday ((b)(6) 2018) and was recovering.The patient's weight at the time of the event is unknown.No further complications were reported or anticipated.Reference regulatory report #3004209178-2018-14057 for the manufacturer's report regarding the difficulty trying to replace the catheter.

Manufacturer Narrative

Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer's representative on 2018-jun-29.It was clarified that "link" was a typo and was supposed to say kink.Regarding the reported decrease in efficacy, it was clarified that the patient's mother stated that there had been a change in tone, but it was noted by the physician that disease had progressed.It was reported that the patient's tone is now under control.The rep stated that as far as she knew, the patient recovered well.No further complications were reported or anticipated.

Manufacturer Narrative

Device code no longer applies.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer's representative on 2018-jul-11.It was clarified that prior to the inability to aspirate during the pump replacement on 2018 (b)(6), no previous concerns with the catheter were stated at the time of surgery.Regarding the suspected kink or occlusion, it was stated that nothing was found.It was noted that there was no imaging of the catheter in-vivo.

Manufacturer Narrative

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

Manufacturer Narrative

Concomitant medical products: product id 8782 serial# (b)(4).Implanted: (b)(6) 2015.Product type catheter product id 8780 serial# (b)(4).Implanted: (b)(6) 2015.Product type catheter 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.

Event Description

Addition information was received from a consumer regarding a patient indicated that when the patient started with a drug concentration of 500 mcg/ml in (b)(6) 2018 he was loose but since then the concentration had been gradually increased to 2000 mcg/ml until 2018-apr and that he was at 3000 mcg/ml in 2018-may but that it was not helping him and he was tight.It was reported that the pump was replaced and nothing was found wrong with the removed pump.The catheter was not found to be blocked and nothing was wrong with it so it was not replaced.The caller stated that since the pump replacement the baclofen concentration was at 500 mcg/ml the patient was loose and she wanted to find out why.It was noted that the neurosurgeon said it was due to the concentration but the rehabilitation facility said it was not the concentration causing the symptoms to be better.The caller stated that they did not do a dye stu dy nor a ct scan prior to replacing the pump.The situation was reported to be resolved.No further complications have been reported as a result of this event.

• 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: 7627271
• MDR Text Key: 111975077
• Report Number: 3004209178-2018-14060
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: 10/04/2018

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: 06/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2018
• Initial Date FDA Received: 06/21/2018
• Supplement Dates Manufacturer Received: 06/29/2018; 06/29/2018; 08/23/2018; 08/08/2018
• Supplement Dates FDA Received: 07/11/2018; 07/12/2018; 08/27/2018; 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 23 YR