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

Model Number 8637-20

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 09/28/2022

Event Type  Injury  

Event Description

Information was received from the company representative (rep) via regarding patient receiving baclofen (181 mcg/day/145 mcg/day)/morphine (3.6 mg/day/2.9 mg/day)/clonidine (72 mcg/day/ 29.11 mcg/day) via implantable pump.It was reported that the patient presented for surgical exploration of intrathecal baclofen treatment (itb) catheter/pump.His healthcare provider (hcp) determined his pump was flipped and the hcp was unable to fill reservoir.The hcp requested prophylactic replacementof the pump during the planned surgical intervention.Upon opening the pump pocket, the surgeon found that the pump catheter was twisted multiple times (he voiced his strong suspicion that the pump had been flipped multiple times).Following disconnecting and straightening the twisted portion of the catheter and reconnecting it to the pump, the hcp attempted to withdraw cerebrospinal fluid (csf)/drug from the cap and he was unable.He replaced the pump (proximal) portion of the 8780 catheter and reconnected it to the pump and was still unable to aspirate from the catheter access port (cap).Therefore, he replaced the spinal portion and the pump portion of the catheter.Twenty percent decrease in drug was recommended by the treating physician and programmed by the other hcp at the time of replacement.The patient had a combination therapy of baclofen 500 mcg/morphine 10 mg/clonidine 200mcg/ml in his pump.Expected volume in the pump reservoir was 8 and actual volume withdrawn and placed from the old pump to the new pump was 10.The rate initially was 181 mcg/day baclofen/3.6mg/day morphine/72mcg/day clonidine.Following the 20% decrease ordered by gopal; baclofen1 45mcg/morphine2.9mg/clonidine mcg/day.Later in the pacu, the patients blood pressure was unsuitably low, and the hcp ordered a 50 % reduction in dose which was updated by intensivist by another hcp.(72.77mcg baclofen, 1.4mg morphine and 29.11 mcg clonidine per day.On (b)(6) 2022 at 10:30 am in response to the patient's continued low blood pressure, the hcp ordered a further 50% reduction of the dose which was updated by another hcp.The patient at the time i last observed him was being cared for in the icu; he was awake, alert, talkative and had no complaints of pain or spasms at 11:30 am on (b)(6) 2022.His care/case was discussed by hcp in my presence with another hcp who stated that he concurred with the hcp orders.2022-10-05 initial reporter (rep) document contains no new information.2022-oct-21 rtg0364298 (hcp) no new information.2022-11-04 rtg0364298 (hcp) additional information was received from the healthcare provider (hcp) indicated, the pump refill they could not aspirate was june or july" the patient also stated that the catheter was kinked.The patient stated they made a few increases in april or may and these were not effective.

Manufacturer Narrative

Concomitant medical products: product id 8780, serial# (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 19-jun-2021, udi#: (b)(4).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.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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15772937
• MDR Text Key: 303545667
• Report Number: 3004209178-2022-14805
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2022
• Date Device Manufactured: 10/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male