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

Model Number 863720

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Itching Sensation (1943); Nausea (1970); Oversedation (1990); Pain (1994); Skin Discoloration (2074); Vomiting (2144); Discomfort (2330); Numbness (2415); Post Operative Wound Infection (2446); Fluid Discharge (2686); Alteration in Body Temperature (4568); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative on (b)(6) 2020 regarding a patient receiving morphine (25mg/ml at 13.988mg/day) via an implanted infusion pump.It was reported that the patient had a previous pump system removed for infection.The event date was unknown and there was no information available on the device explanted due to infection.

Manufacturer Narrative

Continuation of d10: product id: 8711, lot#serial#: (b)(6), implanted: on (b)(6) 2006, explanted: on (b)(6) 2007, product type: catheter.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 healthcare provider indicated that the pump was replaced and the issue was resolved.It was unknown where the explanted device was.

Event Description

Additional information was received from a healthcare provider (hcp) via a company representative.Office procedure notes from (b)(6) 2007 were provided regarding a pump adjustment and pocket inspection.The patient¿s height was 71 inches, and their weight was 225 pounds.The patient¿s problem list / medical history included lumbar radiculopathy (right), post laminectomy syndrome, lumbar fusion, lumbar degeneration / lumbosacral disc, r/o obstructive sleep apnea, malignant neoplasm (testes), and post-surgical spinal pump implant.The pump administered morphine with concentration 10 mg/ml at a dose rate of 2.283 mg/day and the prior dose rate was 1.901 mg/day.The patient¿s chief complaint was pain in his low back; was at a 7 at rest and an 8 with activity on a scale of 10.The pain was decreased by rest, medication, lying down, and quiet.The pain was increased by sitting, standing, and activity.Other symptoms included nausea and vomiting (rarely), sedation, weakness, numbness, itching, and difficulty voiding.The effect of pain management at the time of the visit was described as somewhat improved.The specific issues listed was pain in his low back and his left side of the pump incision.The patient presented with red, dry scaling area from the lateral left end of the pump pocket incision.The area had been hot and red.At the time of the visit, it was not hot but was red.The site was tender.The patient was afebrile.The patient was found to have a stitch abscess associated with implant of his das and he was started on cipro and a complete blood count (cbc) and sedimentation rate was obtained.Labs were collected on (b)(6) 2007.The sedimentation rate (westergren) was 20 (normal range: 0-15).It was noted that the patient indicated their redness had reduced and the area of redness was less, and it had less discomfort in it.Regarding the assessment / plant, the wound revealed an area of redness less than that circled at his last appointment.There was no opening or drainage and no induration or fluctuation or edema.The patient¿s white count was 9.1 and a sedimentation rate of 20 consistent with his infection.The patient was to have no refills after (b)(6) 2007 unless the patient was evaluated in the office for monitoring.The patient¿s wound was improving, and he was tolerating cipro well.The patient¿s pain was being controlled well with methadone and das.The patient¿s medication after this update included: methadone hcl 10 mg tab, lisinopril 20 mg tab, lexapro 10 mg tab, trazodone hcp 50 mg tab, prilosec 10 mg cpdr, infumorph 200 10 mg/ml inj soln (morphine sulfate) for intrathecal drug administration, and cipro 500 mg tab.The patient was to continue with cipro and rtc in two days for another wound check.On (b)(6) 2007 the patient had undergone a procedure for explant of their pump and catheter.The preoperative diagnosis was infected intrathecal drug administration system.The post-operative diagnosis was the same.It was noted at the time of the procedure that the posterior wound did not appear infected, and this wound was therefore opened first.The patient¿s anterior wound had appeared infected.The pocket appeared somewhat beefy red and was oozing and it was difficult to control hemostasis.

Manufacturer Narrative

Continuation of d10: product id 8711 serial# (b)(6) implanted: (b)(6) 2006 explanted: (b)(6) 2007 product type catheter.D3 and g8 update: regarding additional information received, the manufacturer /fda site id for this event is 3004209178.H6 update: the previously applied conclusion code 22 is no longer applicable.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): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos,pr PR 00777
• MDR Report Key: 11013376
• MDR Text Key: 222004056
• Report Number: 2182207-2020-01494
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Report Date: 04/08/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2008
• Device Model Number: 863720
• Device Catalogue Number: 863720
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 03/17/2021; 04/01/2021
• Supplement Dates FDA Received: 03/30/2021; 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 102