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

Model Number 8637-40

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Muscular Rigidity (1968)

Event Date 06/17/2022

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a company representative regarding a patient receiving gablofen (1000 mcg/ml at 362 mcg/day) via an implanted pump.It was reported that the patient was admitted to the hospital with return of spasticity.A cap (catheter access port) study was done on (b)(6) 2022 and the physician was unable to withdraw csf (cerebrospinal fluid).The patient was taken to surgery the next day for a full pump/catheter revision.The hcp replaced the catheter due to its age.The pump was also replaced.The pump was functioning (no alarms/the logs were clear), however, there was a small area along the scar on the pump pocket that had an open wound.As a precautionary measure, the new pump was implanted at a different site.It was noted that there were no environmental, external, or patient factors that may have led or contributed to the issue, and it was indicated that the hcp had no further information to provide regarding the event.Following the procedure, the pump dose in the new pump was reduced to 150 mcg/day.

Manufacturer Narrative

Concomitant medical products: product id 8703, lot# j93117819, implanted: (b)(6) 1993, product type catheter.Product id 8596, lot/serial# (b)(4), implanted: (b)(6) 2006, product type catheter.Other relevant device(s) are: product id: 8703, serial/lot #: (b)(4), udi#: (b)(4) ; product id: 8596, serial/lot #: (b)(4), ubd: 28-sep-2006, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

H3: the pump was returned and the device passed all testing in the laboratory and no anomalies were identified.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: 14785641
• MDR Text Key: 294564010
• Report Number: 3004209178-2022-08018
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• 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
• Treatment: "SEE H10...."
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male