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

Model Number 8637-40

Device Problem Noise, Audible (3273)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Manufacturer Narrative

Product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter; product id: 8598a, serial# (b)(4), implanted: (b)(6) 2018, product type: catheter; product id: 8578, lot# hg1w1tx04, implanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

On 2020-mar-17, information was received from a manufacturer representative (rep).The information was confirmed with the physician /account.The cause of the clicking coming from the pump was unknown to the rep.The cause of the pump popping out more was "believed to be patient's body habitus".The pump would be returned, but no analysis was requested.

Manufacturer Narrative

Product id 8596sc, serial# (b)(4), implanted: (b)(6) 2018.Product type catheter product id 8598a, serial# (b)(4), implanted: (b)(6) 2018.Product type catheter, product id 8578, serial# (b)(4), implanted: (b)(6) 2018.Product type catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2020, information was received from an healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient receiving lioresal (unknown dose and concentration) via an implantable pump for intractable spasticity.It was reported the patient's mother voiced concerns about the position of the patient's pump.She felt that the pump "popped" out more and was much more prominent than it ever had been.The patient's mother "has heard some clicking coming from the pump pocket at times when she picks the patient up.The patient's mother also worried about how stretched the patient's skin was over the pump edges.It was also stated, "baclofen pump prominent and sticking out more than in the past.Skin very thin, but intact along the lateral and superior edge of the pump.The gray metal of the pump visible under these areas".Surgical intervention was planned and scheduled for (b)(6) 2020.

Manufacturer Narrative

Continuation of d11: product id 8596sc lot# serial# (b)(6) implanted: (b)(6) 2018 product type catheter product id 8598a lot# serial# (b)(6) implanted: (b)(6) 2018 product type catheter product id 8578 lot# hg1w1tx04 serial# implanted: 2018-03-23 explanted: 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.

Event Description

On 2020-nov-04, additional information was received from the manufacturer representative (rep).The rep reported they were unable to be there for the explant case, therefore, the pump was disposed of.

• 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: 9838272
• MDR Text Key: 186337056
• Report Number: 3004209178-2020-05505
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention