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); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Aspiration Issue (2883); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

Patient Problems Irritability (2421); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial (b)(4), implanted: (b)(6) 2014, product type: catheter.Product id: 8782, serial (b)(4), implanted: (b)(6) 2014, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8780, serial/lot (b)(4), ubd: 01-oct-2016, (b)(4).Product id: 8782, serial/lot (b)(4), ubd: 25-jul-2016, (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was provided by a healthcare provider (hcp) via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver an unknown type of baclofen (concentration and dose unknown), indicated for intractable spasticity.On (b)(6) 2018, it was reported by a hcp that there were 15 milliliters (ml) of drug remaining in the pump reservoir when 8 ml had been expected.The event date was asked but unknown.It was stated that in a previous note by a different physician, there was a small discrepancy of an unknown volume, and so they decided to investigate via dye study.It was stated that the patient is well; however, per the patient¿s mother, the patient is waking up irritable.It was noted that the hcp believed that the mother might be over-exaggerating, as she has not noticed any changes clinically.It was indicated that there were no environmental, external, or patient factors that may have led or contributed to the issue.The pump was interrogated normally as part of diagnostics/troubleshooting.No interventions had been taken at the time of the report.The issue was not considered resolved.It was stated that the hcp would be scheduling a dye study to rule out the pump/catheter.It was noted that the patent is being filled with the pump upright in the wheel chair, and they need to rule out that all the medicine is actually being taken out at each refill.Surgical intervention did not occur; it was planned but had not been scheduled.At the time of the report, the patient's status was listed as ¿alive ¿ no injury.¿ the patient¿s medical history and weight were asked but would not be made available due to a legal/confidential reason.Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer.The rep indicated that they would update the report once the dye study was complete.They did not have printouts as they did not meet with the patient.The rep had no further information the time of the report and indicated that they would not have more information for at least one month (until the dye study is performed).No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare professional (hcp) via a manufacturer's representative (rep).It was reported that the patient was receiving 2,000 (no units reported) morphine of an unknown daily dose.The patient's pump reservoir volume had been inaccurate.There was a lot more drug than what the clinician programmer said there should be.This happened for the last 2 or 3 refills.The patient did not fall or have any external factors that they knew of.The hcp attempted to do a dye study on (b)(6) 2018 but was not able to aspirate the catheter so dye was not injected.The issue was not resolved at the time of this report.Surgical intervention was planned and the patient's status was "alive - no injury".

Manufacturer Narrative

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

Event Description

Additional information received from a healthcare professional (hcp) reported that the patient has not used they pump since 2017 due to a catheter issue (migration).The hcp stated that the patient had return of symptoms and they did multiple dye studies which showed catheter migration.The hcp stated they put preservative free normal saline (pfns) in the pump and the patient has not received therapy since.The hcp stated the pump was now at end of service (eos).

• 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: 7534138
• MDR Text Key: 108915587
• Report Number: 3004209178-2018-11523
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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,Followup,Followup
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• 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: 11/18/2021
• Date Device Manufactured: 09/02/2014
• 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): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male