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

Model Number 8637-40

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product(s): product id: 8780, serial# (b)(4), product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a company representative regarding a patient who was receiving an unspecified drug of unspecified concentration at an unspecified dose rate via an implantable pump for an unspecified indication for use.On (b)(6) 20190, it was initially reported that the company representative was in the middle of the case in the operating room and was requesting assistance with programming.A pump replacement and catheter revision were being done today ((b)(6) 2019).The original catheter length was 114.3 mcg and they had removed 27.9 of the pump segment from the model 8780 catheter component and added 73.7 cm (model 8784).The new catheter length was 160.1 cm and the catheter volume was 0.352 ml.It was noted that the physician chose not to aspirate the catheter tip and did not wish to do a back table prime.It was being considered not to prime as drug could be pushed that was still remaining in the tip.No further details could be collected at the time of the report.On 2019-dec-26 the company representative clarified the patient¿s name, date of birth, and weight.The serial number of the catheter involved with the event was also clarified.Regarding the reason for pump replacement, the pump was noted as having been at end of life (eol).The catheter flow at the time was found to be insufficient.They had cut the spinal segment of catheter to assess flow.After cutting they did a catheter access port (cap) and could flush that catheter, so they then replaced the spinal segment of the catheter.Regarding the cause of the issue, it was noted that it was an old catheter.Regarding the current status of the explanted device, it was indicated that it would not be returned and there was not an issue that needed evaluation.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d11: product id 8780 lot# serial#(b)(6) implanted: (b)(6)2013 explanted:(b)(6)2019 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

The rep reported that the revision occurred on(b)(6)2019.¿the pump was in prp so there was no reason to send it in.¿ ¿the catheter did not flow so the surgeon opted to revise it with a replacement per normal procedure.¿ there were no further complications reported/anticipated.

• 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 MN 00777 1200
• MDR Report Key: 9532604
• MDR Text Key: 173252095
• Report Number: 3007566237-2019-02630
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Type of Report: Initial,Followup
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10...."; SEE H10....
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 117