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

Model Number 8637-40

Device Problems Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

Patient Problems Scar Tissue (2060); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2021, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 08-dec-2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (company representative, consumer) regarding a patient who was receiving dilaudid (hydromorphone) (16 mg/ml at 8.24 mg/day), fentanyl (500 mcg/ml at 257.5 mcg/day), and clonidine (300 mcg/ml at 154.5 mcg/day) via an implantable pump for spinal pain and failed back surgery syndrome.It was reported that the patient told the company representative their pump started making noises (alarming) last night.The rep interrogated the pump and confirmed that the empty reservoir alarm was going off.The rep asked how long the pump could go empty before it was damaged.Technical services explained that there is no specific cut off and the pump should never be empty, they have not seen a pump get damaged for being empty for one day.Additional information was received from the rep on 2021-02-24 who reported that the cause of the empty reservoir alarm was unknown as the pump was not empty, the reservoir had 24.5 ml in it.Per the healthcare provider, the catheter was partially occluded.The catheter was removed and replaced with a new 8780.The pump reservoir was emptied and refilled.The issue was resolved and the patient's weight was unknown.Additional information was received from the rep on 2021-02-25 who reported that the cause of the partially occluded catheter was that the patient had significant scar tissue in the pocket that had adhered to catheter in multiple locations causing several partial occlusions.The explanted catheter was discarded.

• 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: 11453526
• MDR Text Key: 238871345
• Report Number: 3004209178-2021-04014
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2021
• Date Device Manufactured: 02/01/2017
• 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: 67 YR