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

Model Number 8637-40

Device Problem Occlusion Within Device (1423)

Patient Problem Pain (1994)

Event Date 10/05/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8709, lot# l71599, implanted: (b)(6) 1999, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a clinical study regarding a patient receiving unknown drug via an implanted pump.The indication for use was non-malignant pain.It was reported that during post op follow-up the patient stated no getting relief from the pump.It was noted the patient was examined on (b)(6) 2017 and a possible catheter malfunction was noted.The device diagnosis was catheter occlusion and the clinical diagnosis was malfunction of intrathecal catheter of implanted drug delivery system.It was indicated the event was related to the device or therapy.The catheter was explanted and replaced on (b)(6) 2017.The issue resolved without sequelae on (b)(6) 2017.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider via a clinical study on 2018-mar-28.It was reported that the clinical diagnosis was "not" relief of pain after replacement of implanted drug delivery system.

Manufacturer Narrative

Concomitant medical products: product id: 8709, lot# l71599, implanted: (b)(6) 1999, product type: catheter.Udn# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from healthcare provider (hcp) via a clinical study indicated the cause of the catheter occlusion was not determined.The patient's baseline weight was 248 pounds.No further complications were reported/anticipated.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7373566
• MDR Text Key: 103562437
• Report Number: 3004209178-2018-05804
• 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: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/26/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2018
• Initial Date FDA Received: 03/27/2018
• Supplement Dates Manufacturer Received: 03/28/2018; 04/25/2018
• Supplement Dates FDA Received: 03/30/2018; 04/26/2018
• Date Device Manufactured: 08/21/2017
• 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: 59 YR
• Patient Weight: 112