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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Muscular Rigidity (1968); Pain (1994); Dizziness (2194); Abdominal Distention (2601)

Event Date 11/15/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 8709sc, lot/serial#: (b)(4), implanted: (b)(6) 2010, product type: catheter, ubd: 13-jul-2012, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiving gablofen (2000 mcg/ml at 564.8 mcg/day) via an implantable pump for intractable spasticity and multiple sclerosis.It was reported that the patient had experienced a mild sporadic increase in spasticity at times during the day depending on the position the patient was in, coupled with getting back more drug at her last refill appointment on march 10.The expected volume at her last refill was 6.5 ml and 12.5 ml was the actual amount removed.  the patient indicated they seemed to be able to tell a difference based on the position their body was in.The patient did not notice any issues if sitting or in the upright position, but more so when lying down.  a pump dye/rotor study was performed on march 23.  1 cc of drug was aspirated from the  catheter access port (cap) during the catheter study.The interventional radiologist indicated that although he was able to push the dye, it pushed harder than most times.Along the course of the catheter, at one point there appeared to be a sharp turn in the catheter perhaps contributing to the difficulty of pushing the dye.Dye was observed at the catheter tip.It was believed that the patient¿s symptoms were related to a positional kink in the catheter. no interventions were taken at the time of the report.

Event Description

Additional information was received from the healthcare provider indicated that the patient had pain in their abdomen and chest.The patient's dose was increased by 5% to help resolve symptoms.During the refill procedure it was noted that the pump clock was 3 minutes behind the programmer and had to be reset; the patient also had sensitivity to the pump location during the procedure.The expected reservoir volume was 8 and the actual reservoir volume was over 11 ml.It was noted that the patient was having gastrointestinal issues (bloating, shortness of breath and lightheadedness) which cause was unknown but patient felt may be related to baclofen withdrawal.A catheter injection was planned to determine if there were any granulomas.

Manufacturer Narrative

Continuation of d10: product id 8709sc lot# serial# (b)(6) implanted: 2010(b)(6) explanted: product type catheter 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: 11570879
• MDR Text Key: 242453624
• Report Number: 3004209178-2021-04945
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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,health
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR