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); Communication or Transmission Problem (2896); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problems Shaking/Tremors (2515); Twiddlers Syndrome (4563)

Event Date 02/23/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2021, product type: catheter.Product id: 8781, serial# : (b)(4) , implanted: (b)(6) 2015, product type: catheter.Product id: 8780, serial#: (b)(4) , implanted: (b)(6) 2015, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4) , ubd: 24-aug-2023, udi#: (b)(4) ; product id: 8781, serial/lot #: (b)(4) , ubd: 13-apr-2017, udi#: (b)(4) ; product id: 8780, serial/lot #: (b)(4) , ubd: 09-dec-2016, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a healthcare provider (hcp) via a company representative regarding a patient receiving morphine (6.7 mg/ml at.7634 mg/day) and bupivacaine (30 mg/ml at 3.418 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.The patient reported that he thought he was getting withdrawal symptoms/he was feeling shaky.Per the patient, the pump flipped.He stated that he had to move it up to get the ptm (personal therapy manager) to read it.He felt like he was only getting therapy some of the time and his wife was giving him supplemental medication when this happened.It was noted that the pump did appear to be seated sort of sideways in the pocket when he sat.The physician attempted to aspirate the catheter on (b)(6) 2022 and was unable to.The patient was going to be scheduled for a pocket revision and possible catheter revision.There were no known environmental, external, or patient factors that may have led or contributed to the issue.The issue was not resolved at the time of the report, and it was indicated that the hcp had no further information to provide regarding the event.

Event Description

Additional information received from a company representative (rep) reported that since the pump had been implanted the patient would twiddle with the pump causing numerous pump flips.The pump was reported to have been moved to the back area and the catheter was revised.It was reported that due to the flipping part of the catheter broke off and they were unsure about the total intrathecal length.It was reported the physician was going to estimate a little shorter by 10 cm.The company representative inquired about how long it would take to fill the volume value at the current rate of 0.1139 ml/day or 0.0047 ml/hr.

Manufacturer Narrative

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.

Manufacturer Narrative

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.

Event Description

Additional information was received from the healthcare provider via a company representative (rep) and it was indicated the pump repositioning resolved the event that it was just moved on (b)(6) 2023 and as of now, the event was resolved, however; "we don't really know yet".

• 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: 13618274
• MDR Text Key: 286238829
• Report Number: 3004209178-2022-02561
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422608
• UDI-Public: 00763000422608
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2023
• Date Device Manufactured: 08/05/2021
• 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: 74 YR
• Patient Sex: Male