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); Material Separation (1562); Failure to Disconnect (2541); Material Integrity Problem (2978); Unintended Movement (3026); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: catheter; product id: 8590-1, lot# n781832, implanted: (b)(6) 2018, product type: accessory.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4); product id: 8590-1, serial/lot #: n781832, ubd: (b)(6) 2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was provided by a healthcare provider via a manufacturer¿s representative regarding an implantable intrathecal pump intended to deliver dilaudid [1000 mcg/ml] at 121 mcg/day, indicated for non-malignant pain and failed back surgery syndrome.It was reported that the patient¿s pump was moving in the pocket.The event date was asked but would not be made available due to a legal/confidential reason.It was indicated that there were no environmental, external, or patient factors that may have led or contributed to the issue.The physician met with the patient in the office and observed that the pump was moving in the pocket.As an action/intervention taken to resolve the issue, a pocket revision was scheduled.Surgical intervention occurred.The case was scheduled as pocket revision.The pump appeared to be flipping in the pocket.The physician opened up the pocket and the mesh pouch was not adhered to the tissue and the catheter was twisted many times.The physician removed the sutureless pump connector, and it separated into two pieces.The catheter was partially explanted on (b)(6) 2018.It was reported that the catheter had a piece sheared near the connection and the proximal catheter was replaced.The issue was resolved at the time of the report and the patient's status was listed as ¿alive ¿ no injury.¿ no patient symptoms were reported.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.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturing representative (rep).It was reported the rep was in possession of the explanted catheter segment and planned to return the piece to the manufacturer.

Manufacturer Narrative

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

Event Description

Additional information received from a manufacturer representative and a healthcare professional (hcp) via a clinical study indicated the device diagnosis was pump inversion.The outcome of the event was noted as ongoing.(please note: this conflicts with the previously reported information that the issue was resolved.) the etiology of the event indicated the relationship of the event to the device or therapy was not related and indicated the relationship of the event to the implant procedure was possibly related.No further complications were reported.

Manufacturer Narrative

The catheter was returned, and analysis found damage to the transition tube.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturing representative (rep).It was reported the doctor revised the pump segment of the catheter and the pump remains implanted.The rep did not know if the explanted portion of the catheter would be available for return at the time of the report (2018(b)(4).

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) via a clinical study indicated a revision of the pump pocket occurred on 2018(b)(6).No further complications were reported.

Manufacturer Narrative

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

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) via a clinical study indicated the outcome of the event resolved without sequelae on (b)(6) 2018.No further complications were reported.

Event Description

Additional information received from a healthcare provider via a clinical study reported the patient's pocket and catheter were revised on (b)(6) 2019.

Manufacturer Narrative

Concomitant medical products: product id 8780, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: catheter, product id: 8590-1; lot #: n78183, implanted: (b)(6) 2018, product type: accessory.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: 7686884
• MDR Text Key: 113952916
• Report Number: 3004209178-2018-15737
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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,Followup,Followup,Followup
• Report Date: 05/02/2019

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: 09/14/2019
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/13/2018
• Supplement Dates Manufacturer Received: 08/23/2018; 09/19/2018; 10/02/2018; 10/02/2018; 10/18/2018; 11/16/2018; 11/17/2018; 05/01/2019
• Supplement Dates FDA Received: 08/23/2018; 09/20/2018; 10/03/2018; 10/03/2018; 11/02/2018; 11/16/2018; 11/19/2018; 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 82