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

Model Number 8637-20

Device Problem Excessive Heating (4030)

Patient Problem Burning Sensation (2146)

Event Date 12/08/2020

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 regarding a patient receiving dilaudid via an implanted pump.The indication for pump use was spinal pain.The patient reported that she was working on having her pump removed because she was having a lot of problems with burning and it felt like it was coming from the pump.The burning sensation was in a band all the way across from her lower abdomen to the top of her thighs and it felt like burning from the inside out.She had been to two ers (emergency rooms) and had all kinds of tests done which indicated that the pump was working correctly, and the catheter was in the correct place.She was currently in the process of weaning off the medication to have the pump removed.She mentioned that she normally only had 77 days between refills but had gone way longer than that this time and wasn't sure if it was because the hcp (healthcare professional) had started weaning her off the medication or not.She stated that she had recently switched doctors after being dropped by her prior doctor.She had a consultation with the new hcp tomorrow but couldn't remember the hcp¿s name.She stated that she had memory problems.

Event Description

On 2021-jan-11, additional information was received from the patient.The cause of the burning sensation was requested.The patient stated, "i am feeling a burning about pump level at abdomen across and top of both thighs.Not as yet resolved.Do not know cause." the patient had "no idea" of the actions/interventions taken or planned because their hcp dropped them as a patient.The patient listed a new hcp as their new pump managing hcp, but stated that they think they cannot properly care for them as their office was two hours away from their home.

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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 10977307
• MDR Text Key: 220485056
• Report Number: 3004209178-2020-21495
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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: 05/28/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 121