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

Model Number 8637-40

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from multiple sources (manufacturer representative, healthcare provider, consumer) regarding a patient who was receiving prialt (ziconotide) with concentration 25 mcg/ml at a dose rate of 4.996 mcg/day via an implantable pump for non-malignant pain and degenerative disc disease.It was reported that the patient's pump had gone empty.The company representative was at a catheter revision on (b)(6) 2020 for a catheter issue.The catheter issue was regarding a catheter of an alternate manufacturer.It was further noted that while talking with the patient, the patient stated her "pump went empty sometime (b)(6) 2020" and does not believe anyone filled it with preservative free normal saline (pfns).The date (b)(6) 2020 is considered an approximate date ofevent (specific month and year known only).The reason for the report was they were considering if pump replacement was recommended regarding it having been empty.It was reviewed that this would be the healthcare provider's medical decision.It was further reported that the company representative would see if the hcp wanted to do a total system replacement, since they were already replacing the catheter.The company representative had no further history regarding the empty pump at this time.The patient's weight was noted indicated as having been unknown.No patient symptoms were reported.

Event Description

Additional information received reported that the patient stated that their catheter from a different manufacturer hadn't been working properly so they let the pump go empty.The patient did not experience any symptoms related to the empty pump.The pump and catheter were replaced on (b)(6) 2020.The issue was resolved.

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.

• 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: 10836414
• MDR Text Key: 216130805
• Report Number: 3004209178-2020-19946
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR