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

Model Number 8637-20

Device Problems No Audible Alarm (1019); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Muscular Rigidity (1968); Scar Tissue (2060); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Malaise (2359); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Cognitive Changes (2551); Insufficient Information (4580)

Event Date 11/03/2019

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 consumer via a user facility regarding a patient receiving unknown baclofen via an implanted pump.It was reported that mid-summer the patient began to have increased spasticity in their legs which resulted in the patient going to the doctor three times for an increase in their baclofen pump dose.This resulted in little to no benefit to the patient.Since the pump was due to be replaced in 2020, the hcp scheduled pump replacement surgery on (b)(6) 2019.The patient was put on oral baclofen as a supplement.The patient's spasticity worsened and the patient could not bend their legs to get out of bed.The patient went to the emergency room and after several hours of being examined and tests performed, the patient was admitted for baclofen withdrawal symptoms.The patient spent 7 days in the hospital and the hcp concluded the pump had failed or malfunctioned.The manufacture representative went to the er two different times and did a diagnostic test of the pump and it showed it was working.The patient was put on a high dose of oral baclofen and tried another muscle relaxer along with it.The patient felt terrible and started having hallucinations.It was noted at one point the patient felt like they were going to die.The patient's pump was replaced and once the pati ent's spasticity level was to where the patient could walk again, they were discharged.The patient was still on a high dose of baclofen, wasn't sleeping, and was having hallucinations.The hcp ordered home healthcare which included physical, occupational, and spe ech therapy.It was noted the diagnostic tests showed the pump was functioning but the patient noted they had baclofen withdrawal symptoms.It was noted if the patient had not gone to the emergency room, this could have been fatal.The pump had two alarms on it to indicate a problem and neither alarm sounded.It was noted the hcp had not way of knowing how much baclofen they were getting and their symptoms of extreme spasticity and feeling unwell were indicators that something was wrong with the pump.A new pump was implanted on (b)(6) 2019.

Event Description

Following the patient¿s increase in spasticity and symptoms of baclofen withdrawal, it was found that the patient did have intermittent response to boluses through the intrathecal drug system.However, the patient was placed on oral medication to prevent full withdrawal until surgery was conducted on (b)(6) 2019.At the time of surgery, fluoroscopy was used to localize the catheter tip which was seen at t8.The pump was exposed and subsequently removed from the pocket.The sideport was aspirated and cerebrospinal fluid (csf) flow was good and easy.The catheter was then disconnected from the pump, and there was spontaneous flow from the end.The physician cleared the catheter end of debris and connected a new pump.The rest of the catheter was examined in the pocket; the catheter did seem to have some curling within scar tissue in the pocket.The catheter was freed until the connector of the two catheter segments was seen.It was noted that the connector segment was carefully examined and found to have adequate catheter within each side.The sideport was aspirated again, and very easy return of csf was seen.

Manufacturer Narrative

Continuation of d10: product id 8780 serial# (b)(6) implanted: (b)(6) 2013 product type catheter medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.

Manufacturer Narrative

H3: the pump was returned, and analysis found no anomaly.H6: all previously reported method and result codes no loner apply to this event.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.

Event Description

Additional information received from a healthcare provider reported the device stopped delivering medication.It was noted that there were no alarms sounding.The pump was interrogated and hcp notted "not enenlightening".The pump malfunction and symptoms resolved after the pump was replaced.The patient's weight was 69 kg.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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: 9781988
• MDR Text Key: 189447007
• Report Number: 3004209178-2020-04539
• 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: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/16/2020

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: 10/28/2014
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/03/2020
• Supplement Dates Manufacturer Received: 05/18/2020; 05/29/2020; 12/14/2020
• Supplement Dates FDA Received: 05/19/2020; 06/02/2020; 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 69