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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)

Patient Problems Itching Sensation (1943); Muscular Rigidity (1968); Twitching (2172); Therapeutic Response, Decreased (2271); Irritability (2421)

Event Date 02/20/2018

Event Type  Injury  

Manufacturer Narrative

Information references the main component of the system and other applicable components are: product id: 8709sc, lot# (b)(4), serial# (b)(4), implanted: (b)(6) 2011, product type: catheter.\ if information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a health care provider (hcp) via a device manufacturer representative regarding a patient receiving gablofen (2000 mcg/ml at 363.7 mcg/day) via an implantable infusion pump.The indications for use were noted to be cerebral palsy and intractable spasticity.It was reported that on (b)(6) 2018 the patient started experiencing increased spasticity, itching and irritability.A dye study was done on (b)(6) 2018 and dye was visualized leaking in the pump pocket site.The patient was scheduled for a catheter revision/replacement on (b)(6) 2018.There were no environmental, external or patient factors that may have led or contributed to the issue.The issue was not resolved at the time of the report.The patient was being treated with oral baclofen and tranxene.The patient's status at the time of the report was alive - no injury.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 health care provider (hcp) via a device manufacturer representative on 2018-mar-05.It was reported that during the catheter revision, the neurosurgeon visualized fluid in the pump pocket site.When the existing catheter was disconnected from the pump, tissue was observed inside the sutureless connector.The tissue was cleaned out and spontaneous retrograde flow of cerebrospinal fluid (csf) was observed.The surgeon disconnected the existing 7.6 cm sutureless connector from the pin connector and spontaneous retrograde csf flow was observed from the existing implanted spinal segment.A new segment of sutureless connector was spliced onto the spinal segment.After the pump was reattached, the catheter access port was accessed and fluid was withdrawn easily with no bubbles observed.The pump was restarted at 180 mcg/day, which was half of the previous infusion rate.It was noted the leak originated from the juncture of the catheter sutureless connector and the exit port of the pump.The issue was resolved at the time of the update.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 healthcare provider via a clinical study on 2018-mar-05.It was reported that the device diagnosis was catheter occlusion.The etiology of the event further indicated the event was possibly related to the implant procedure, and was related to the lumbar/pump portion of the catheter.

Manufacturer Narrative

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

Additional information was received from a healthcare provider via a clinical study on 2018-mar-05.It was reported that the patient complained of leg twitching on 2018 (b)(6).The clinical diagnosis was baclofen withdrawal and the programming date from the last refill prior to the event was 2018 (b)(6) at 14:10.The patient's mother denied any other disease process or other cause that could mimic or lower baclofen withdrawal.Attempts to wean baclofen on 2018 (b)(6) failed.The event resulted in in-patient hospitalization and an unscheduled clinic or office visit.Diagnostics included oral baclofen with cessation of symptoms on 2018 (b)(6), no abnormalities noted in the logs on 2018 (b)(6), and the previously reported catheter access port (cap) contrast study on 2018 (b)(6) (note: this conflicts with the previous report that the dye study occurred on 2018 (b)(6)).It was further noted that during the study, dye was seen in the intrathecal space as well.The etiology of the event indicated that the event was related to the device or therapy.

Manufacturer Narrative

Analysis of the catheter identified coring/cuts/tears in the seal of the sutureless connector which met leak criteria.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code because, although the device was operating within specifications, medtronic modified the specifications making this the closest code available with respect to this event.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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7316317
• MDR Text Key: 101594227
• Report Number: 3004209178-2018-04416
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/18/2018

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: 09/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 03/06/2018
• Supplement Dates Manufacturer Received: 03/05/2018; 03/05/2018; 03/05/2018; 03/23/2018
• Supplement Dates FDA Received: 03/06/2018; 03/06/2018; 03/22/2018; 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 11 YR
• Patient Weight: 32