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

Model Number 8637-40

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

Patient Problems Erythema (1840); Unspecified Infection (1930); Inflammation (1932); Pocket Erosion (2013); Swelling/ Edema (4577)

Event Date 09/21/2021

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), consumer, and a company representative regarding a patient receiving sufentanil (360 mcg/ml at 160 mcg/day), bupivacaine (32 mg/ml at 14.2 mg/day), and clonidine (300 mcg/ml at 133.44 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.It was reported that the patient noticed an area around the pump that was becoming more sensitive, and the skin was less protective, but didn¿t come into the hospital until this past weekend ((b)(6) 2022) despite the hcp requesting sooner for evaluation.The pump was dehisced/the corner had eroded through the skin and it was infected.The infection started a couple of months ago with just some redness near the pump site.From there, the infection progressed culminating in pump replacement.The pump was explanted on (b)(6) 2022, and a new pump was implanted in a new location on the same side to avoid full explant and ensure the incision closed.The patient had some minor swelling as of (b)(6) 2022.With regards to any environmental, external, or patient factors that may have led or contributed to the issue, it was noted that the patient had no falls or other reported issues.The issue was noted to be resolved.It was indicated that the hcp had no further information to provide regarding the event.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14191873
• MDR Text Key: 289949282
• Report Number: 3004209178-2022-05164
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Date Device Manufactured: 01/23/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 64 YR
• Patient Sex: Female