MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637

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

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930); Seroma (2069); Post Operative Wound Infection (2446)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Citation: turley mc, moore c, creasy jm, et al.Combined primary resection with hepatic artery infusion pump implantation is safe for unresectable colorectal liver metastases.J gastrointest surg.2021.10.1007/s11605-021-05195-8.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Date of event.Please note that this date is based off of the start date of the study as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: turley mc, moore c, creasy jm, et al.Combined primary resection with hepatic artery infusion pump implantation is safe for unresectable colorectal liver metastases.J gastrointest surg.2021.10.1007/s11605-021-05195-8.Abstract: background: colorectal liver metastases (crlm) are the most common cause of disease-specific mortality in patients with colorectal cancer.Hepatic artery infusion (hai) combined with systemic chemotherapy improves survival for these patients.The safety of colorectal resection at the time of hai pump placement has not been well established.Methods: patients with crlm who underwent combined hai pump placement and colorectal (primary) resection or hai pump placement alone were evaluated for perioperative outcomes, pump-specific complications, infectious complications, and time to treatment initiation.These outcomes were compared using comparative statistics.Results: patients who underwent combined hai pump placement and primary resection (n = 19) vs hai pump placement alone (n = 13) had similar demographics and rates of combined hepatectomy.Combined hai pump placement and primary resection group had similar operative time and blood loss (both p = ns), but longer length of stay (6 vs 4 days, p = 0.02) compared to pump placement alone.Overall postoperative complications (21% vs 8%) and pump-specific complications (16% vs 31%) were similar (both p = ns).Infection rates were not different between groups, nor was time to initiation of hai therapy (19 vs 16 days p = ns), or systemic therapy (34 vs 35 days p = ns).Conclusion: combining colorectal resection with hai pump implantation is a safe surgical approach for management of unresectable crlm.Postoperative complications, specifically infectious complications, were not increased, nor was there a delay to initiation of hai or systemic chemotherapy.Investigation of long-term oncologic outcomes for hai pump placement and primary tumor resection in patients with unresectable crlm is ongoing.Reported events: among patients with combined colorectal resections, 79% (15/19) underwent colectomy and 21% (4/19) underwent low anterior resection (lar) (table 2).Additionally, 28% (9/32) of patients had a combined partial hepatectomy and/or ablation in addition to haip placement, including 26% (5/19) in the combined colorectal resection group and 31% (4/13) in the haip-alone group.Of the combined procedures, 18/19 underwent open haip placement and colorectal resections and 1/19 underwent minimally invasive haip placement and colorectal resection (table 2).Despite the additional procedures, median total operative time and estimated blood loss were similar between the combined hai-resection and the haip-only groups.Postoperative length of stay was longer for the combined resection group than for the haip-only group (median 6 versus 4 days, p = 0.02).General surgical complications after the index operation occurred in 4 (21%) patients who underwent combined hai pump placement and colorectal resection and 1 (8%) patient who underwent hai pump placement alone (p = 0.60).These included deep venous thrombosis (dvt, 5%), urinary tract infection (uti, 5%), and fascial dehiscence (11%) in the combined group and surgical site infection (ssi) in the haip-only group.The rate of hai-specific complications was also similar between groups (16% versus 31%, p = 0.57).These included pump pocket seroma (11%), gastroduodenal artery pseudoaneurysm (5%), and biliary sclerosis (5%) in the combined group, and pump pocket hematoma (8%), hepatic arterial dissection (8%), extrahepatic perfusion (8%), and pump pocket infection (8%) in the haip-alone group.One patient in the combined group accounted for both an early pump pocket seroma and a delayed arterial pseudoaneurysm.The pseudoaneurysm occurred during an episode of pancreatitis approximately 8 months after hai pump placement and following definitive hepatic resection.Perioperative outcomes are fully described in table 2.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13311587
• MDR Text Key: 288851058
• Report Number: 2182207-2022-00097
• Device Sequence Number: 1
• Product Code: LKK
• 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: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8637
• Device Catalogue Number: 8637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2021
• 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): Other
• Patient Age: 51 YR
• Patient Sex: Male