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

Model Number 8637-40

Device Problems Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Fever (1858); Itching Sensation (1943); Muscle Spasm(s) (1966); Seizures (2063); Tachycardia (2095); Deformity/ Disfigurement (2360); Cognitive Changes (2551); No Code Available (3191)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709sc, serial# (b)(4), implanted: (b)(6) 2012, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 30-aug-2013, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional regarding a patient receiving lioresal 2000 mcg/ml for a total dose of 468.5 mcg/day via an implantable pump for intractable spasticity and cerebral palsy.It was reported the healthcare professional (hcp) was inquiring about information on the patient's catheter as the patient was having intrathecal baclofen (itb) (lioresal) withdrawal symptoms.The symptoms that started on (b)(6) 2018 included increased spasms, moaning, jerking, and tachycardia.On (b)(6) 2018 and (b)(6) 2018 the patient's heart rate was 130 (tachycardia) and the hcp was suspecting a catheter issue.On (b)(6) 2018 they refilled the patient's pump and the patient had a little fever then.It was noted they were able to aspirate 3 cc via the catheter access port (cap) and then a prime was done of the catheter volume only.The last pump refill prior to (b)(6) 2018 was (b)(6) 2018.It was noted the patient went to the emergency department (ed) on (b)(6) 2018 and they ruled out an ileus.The next day ((b)(6) 2018) they increased the patient's itb dose and that calmed the patient's symptoms.On (b)(6) 2018 the withdrawal symptoms began again.It was noted that the patient has severe mental retardation due to their cerebral palsy (cp) so they cannot assess if the patient has altered mental status or pruritus.On (b)(6) 2018 the patient experienced a seizure with a single bolus dose 15 to 20 minutes after the bolus, so the family does not want that done again.The patient had no falls or other issues that may have caused the suspected catheter issue.Diagnostic testing was done and it appeared everything was normal as the patient had a work up for gallstones and kidney stones along with blood work and a urine culture, but there was no infection and there were no issues found so all medical issues were ruled out as the cause of the symptoms.The hcp stated g-tube medications were tried which did not help much with the patient's symptoms.They tried oral/g-tube baclofen, lorazepam and clorezepam for the patient's seizures.It was noted that the patient had an allergy to diazepam (makes the patient excited) so they do not prescribe that.The patient was admitted today ((b)(6) 2018) and they will probably replace the catheter as soon as possible per hcp.The location of the symptoms was other.The event date was (b)(6) 2018.No further complications were reported/anticipated.

Event Description

Additional information was received from saol.It was reported that seizure on (b)(6) 2018 following bolue was unknown if it was coi ncidental.Patient had crack in catheter.No further complications were reported.

Manufacturer Narrative

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

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 saol.It was reported that the seizure on (b)(6) 2018 following bolus had further episodes.The withdrawal symptoms were resolved after catheter revision.Concomitant medications and dietary supplements that the patient was taking/receiving at the time of the reported events were clonazepam targeted seizure medications.Patient was discharged from hospital on (b)(6) 2019.No further complications were reported.

• 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: 8204578
• MDR Text Key: 131706003
• Report Number: 3004209178-2018-28505
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 36 YR