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

Model Number 8637-20

Device Problems Inappropriate or Unexpected Reset (2959); Data Problem (3196)

Patient Problems Pain (1994); Malaise (2359)

Event Date 08/18/2021

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 healthcare provider (hcp) regarding a patient receiving fentanyl (2000 mcg/ml at 499.9 mcg/day) and bupivacaine (30 mg/ml at 7.494 mg/day) via an implanted pump.The indication for pump use was malignant pain.The home health nurse reported that she was seeing the patient today to increase her dose and upon interrogation she noted that a reset, safe state, and a pump memory error occurred.She checked the pump logs and they showed that the alarms occurred on (b)(6) 2021.The patient had heard her pump alarming for some time and had increased pain over the course of the last 2 weeks and was taking oral pain meds.The patient was last seen by her hcp (healthcare provider) on (b)(6) 2021 for a cap (catheter access port) procedure.Additional information was received on 27-aug-2021 from the patient¿s managing hcp who reported that today when the pump was interrogated service codes 87 (pump in safe mode) and 101 (pump reset) appeared and the patient was reporting symptoms of feeling awful and her pain returning.The event logs showed the pump reset to minimum rate mode.During the call, the hcp attempted to program the pump out of safe state (minimum rate) and in trying to do so another service code popped up stating that eri (elective replacement indicator) would occur before the next refill.It was noted that the patient heard the alarm, but it seemed to be faint to her.The hcp asked for and was provided the pump off passcode to permanently shut the pump off.

Event Description

B5 - corrected information: the sentence [additional information was received on 27-aug-2021 from the patient¿s managing hcp who reported that today when the pump was interrogated service codes 87 (pump in safe mode) and 101 (pump reset) appeared and the patient was reporting symptoms of feeling awful and her pain returning.] on the initial mdr should have read [additional information was received on ¿27-sep-2021¿ from the patient¿s managing hcp who reported that today when the pump was interrogated service codes 87 (pump in safe mode) and 101 (pump reset) appeared and the patient was reporting symptoms of feeling awful and her pain returning.].

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: 12539361
• MDR Text Key: 273546337
• Report Number: 3004209178-2021-14481
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR