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 Wound Dehiscence (1154); Pocket Erosion (2013); Weight Changes (2607)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

Other relevant device(s) are: product id 8780 lot/serial# (b)(4).Implanted: (b)(6) 2018, product type: catheter.Product id: 8780, serial/lot #: (b)(4), ubd: 11-dec-2019, udi#: (b)(4).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) regarding a patient who was receiving 20 mg/ml of dilaudid at 9 mg/day via an implantable pump for unknown indications for spinal pain.It was reported that there was an issue with the pump.The rep stated that the patient's pump was now eroded through the patient's skin at the pocket site.The hcp noticed about a month ago there was a "pressure point" near the pump.Afterwards, the patient went from weighting (b)(6) lbs to about (b)(6) lbs currently.The patient had told his hcp that he felt like where the catheter connected to his pump it was rubbing up against his skin creating the pressure point.The hcp then put a bandage over the site and brought the patient back in today ((b)(6) 2021) to check out the pocket site.That is when the hcp noticed that the pump and catheter were eroding through the patient's skin and the hole was about the size of a quarter.The hcp told the patient to go to the emergency room and told the patient to tell them to explant the device.The hcp and rep did not believe it was infected at this time and it was more so due to the catheter / pump connection rubbing.The hcp did not plan to culture the site.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11996402
• MDR Text Key: 261843426
• Report Number: 3004209178-2021-09351
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2019
• 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: 06/09/2021
• Date Device Manufactured: 12/20/2017
• 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
• Patient Age: 64 YR
• Patient Weight: 68