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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Misconnection (1399)

Patient Problems Muscular Rigidity (1968); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: neu_unknown_cath, lot#: unknown, product type: catheter.Other relevant device(s) are: product id: neu_unknown_cath, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare provider (hcp) via a distributor representative regarding a patient who was receiving lioresal (500 mcg/ml at 130 mcg/day) via an implantable pump for an unknown indication for use.It was reported drug was not being delivered to the intrathecal space because of a wrong connection of the catheter.The patient experienced an increase in spasticity.Additionally, an incorrect reservoir volume was detected; the programmer showed 9.7 ml but the pump really had around 6 ml.The pump was replaced on (b)(6) 2020 and the issue resolved.The pump would be returned.The patient status was alive - no injury.Further complications were not reported.Additional information was received.A catheter disconnection was not observed.The connection issue was observed at the connection to the pump interface.The "proximal portion to the connection of 4,5 cm was cuta and replaced with a new portion of 6 cm of a 8784 reference." no contributing factors to the catheter connection issue were identified.Additional information was received.The portion of the catheter that was replaced was discarded by the medical team.

Manufacturer Narrative

H3: the pump was returned and analysis found no anomalies.The device passed all laboratory testing.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
• 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: 11156062
• MDR Text Key: 226312733
• Report Number: 3004209178-2021-00602
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/11/2022

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: 02/28/2022
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/12/2021
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2020
• 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 Sex: Female