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

Model Number 8637-20

Device Problems Migration or Expulsion of Device (1395); Positioning Problem (3009); Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Pain (1994); Tingling (2171); Discomfort (2330); Numbness (2415); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Date 10/03/2016

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 fentanyl dose and concentration not reported, via an implantable pump.The indication for use was non-malignant pain.The patient¿s medical history included having a blood clot that collapsed the lung last year.On (b)(6) 2019 the patient reported since monday or tuesday they were unable to get all of her boluses because the ptm (personal therapy manager) locks her out, she waits for time given and then it tells her she has to wait again.The patient stated she was not so much worried about that right now because she does not think her pump is working correctly.The pain was so bad.The patient¿s stomach hurts and was tender where the pump was; it feels numb and tingling.The patient had not fallen.The patient¿s managing physician was leaving his practice and had sent the patient to see a different physician.The patient was currently at the physician¿s office and per the patient ¿he just had me walk and told me to come back in a month." the physician did not look at the pump site where it was tender.The patient couldn't wait that long and something was not right.No further complications were reported regarding the event.

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer on 10-jun-2019 who reported that when she puts the ptm on her stomach it doesn't read it.Last night it took her 5 hours and the other day it took her 14 hours.The patient attempted to use the ptm without an antenna.The patient was never given an antenna.The patient was transferred to repair for a replacement device and an antenna to be sent.Poor communication with the ptm.The patient also stated the pump in her stomach had been moving around and she has to kind of wait and go in one direction with the ptm.She has to press into her ribs sideways and an upward angle.She said it is really uncomfortable.The patient¿s stomach was hurting really bad, more then her back problems and couldn't even walk.The patient had called the hospital because she thought she was going to kill herself and they said they don't deal with pain management people.The patient called a different hospital to see if they would take the pump out and they said they can't take it out without her doctor's approval.No further complications were reported or 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 patient had an issue where they had to press on their ribs which caused discomfort when using the personal therapy manager (ptm).It was further noted that the patient¿s pump was originally placed too high (implanted (b)(6) 2016), so she had surgery in august.

• 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: 8560249
• MDR Text Key: 143411974
• Report Number: 3004209178-2019-08476
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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,Followup
• Report Date: 03/30/2020

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: 02/28/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/25/2019
• Initial Date FDA Received: 04/29/2019
• Supplement Dates Manufacturer Received: 06/10/2019; 03/27/2020
• Supplement Dates FDA Received: 06/11/2019; 03/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR