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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Migration or Expulsion of Device (1395); Material Integrity Problem (2978)

Patient Problems Cerebrospinal Fluid Leakage (1772); Hemorrhage/Bleeding (1888); Pain (1994); Discomfort (2330); Insufficient Information (4580)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 8780, serial#: (b)(4), implanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #:(b)(4), ubd: 17-nov-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received by a healthcare provider (hcp) via company representative (rep) regarding a patient who was receiving dilaudid (5 mg/ml at 2 mg/ml) via implantable infusion pump.It was reported that the patient started to feel symptoms (discomfort around the pump area and felt like she was not receiving her therapy from the pump) when the patient went in for an ultrasound appointment on (b)(6) 2021.Once the patient started to feel symptoms, the patient contacted their hcp.The hcp tried to aspirate the pump and was getting back blood.It was noted that the hcp was unable to access the pump.It was also noted that the pump was flipping.The decision was made to do a pocket revision on (b)(6) 2021.Once in the operating room, the hcp discovered a tear in the catheter.The pump segment of the catheter was replaced and the old pump segment was discarded.The patient's weight was asked but unknown.The patient's medical history was asked and will not be made available.The patient's status at the time of report was alive - no injury.

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.

Event Description

Additional information was received from the patient who reported that she had an ultrasound of her liver.She stated that during the procedure, the ultrasound tech was pushing so hard on the pump and pushing her on the table that she was screaming in pain.Per the patient, the ultrasound tech had snapped the connector that was attached to the spine and the ultrasound tech knotted up the catheter outside of the pump and had manage to flip the pump several times.In the following weeks, she had to go back to have 1.5 liters of blood removed from her abdomen and had to go back again to have more blood removed from her abdomen and the last time they removed spinal fluid from her abdomen.She then had to have emergency surgery and they did a revision of the catheter on (b)(6).Per the patient, the pump had been moving since implant and was still moving, but it was positional.Sometimes it felt farther sometimes closer, but it felt like it was in a different spot each time.It depended on if she was sitting or standing or laying down.

• 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: 12247830
• MDR Text Key: 264764683
• Report Number: 3004209178-2021-11644
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2022
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: "SEE H10."
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR