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

Model Number 8637-40

Device Problems Battery Problem (2885); Insufficient Information (3190)

Patient Problems Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient via a manufacturer¿s representative (rep) regarding the implantable drug infusion device.The drug being delivered was unknown.It was reported that his pain pump seems to be wearing out and is giving him more pain.He has noticed a huge increase in pain since back in (b)(6) 2020.He is doing partial oral pain therapy and pain pump therapy but he is not getting any benefit.His pump was filled last in (b)(6) 2019 and he is due (b)(6) 2020 for his next refill.They reviewed longevity information on the pump.The patient stated he is not sure if he has heard an alarm from the pump at all.It was suggested that the patient contact his healthcare professional (hcp) to have the pump checked and make them aware of his pain levels.There were no further complications reported/anticipated.

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.

Event Description

Additional information was received via a consumer.It was reported that the battery had died and the patient did not realize it.The date (b)(6) 2020 is considered an approximate date of event (month and year known only).The patient was experiencing excessive pain, so he went to the healthcare provider (hcp).It was further reported that the patient was on a flow with the pump where he had more medication during the day and less at night because he would take oral pills the patient was now just on oral pills and his pump replacement was denied.The patient was working with their healthcare provider to get it approved.The pump was noted as having administered hydromorphone of an unknown concentration at an unknown dose rate.On 2020-nov-12 a company representative further reported that the pump battery was dead.Environmental/external/patient factors that may have led or contributed to the issue was unknown.The issue was not resolved.Actions taken to resolve the issue were unknown.The patient was without injury regarding their status as of (b)(6) 2020.

• 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: 10421430
• MDR Text Key: 203368688
• Report Number: 3004209178-2020-14282
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR