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

Model Number 8637-40

Device Problems Premature Elective Replacement Indicator (1483); Pumping Stopped (1503); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8781, lot# unknown, explanted: (b)(6) 2019, product type: catheter.Other relevant device(s) are: product id: 8781, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal lioresal 2000 ug/ml at 950 ug/day via an implantable pump.The indication for use was not reported.It was reported that pump dysfunction occurred.Premature battery depletion [unexpected elective replacement indicator (eri)] and a motor stall occurred.Additionally, it seemed there was ¿something wrong, perhaps a cut¿ with the catheter.There were no environmental, external or patient factors reported that might have led or contributed to the event.The pump and catheter were replaced with urgency.The pump and catheter would be returned to the device manufacturer.The issue was resolved.The patient's status was alive - no injury.The implant date was unknown.Information regarding the patient¿s age, weight, medical history, and other medications was unavailable.No further complications were reported.

Manufacturer Narrative

Product id 8781, lot# unknown,implanted: (b)(6) 2002, explanted: (b)(6) 2019.Product type catheter.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a foreign healthcare professional (hcp) via a manufacturer representative.The catheter lot number was unknown as it was implanted in another hospital in 2002.It was reported that ¿with correct preoperative¿, on (b)(6) 2019 the [replacement] surgery was performed.A replacement pump was implanted, and a new 8784 was placed, of which 23 cm were cut.

Manufacturer Narrative

The returned pump was subjected to a series of standard tests that include but is not limited to visual inspection, alarm output, motor function, and dispense testing.Destructive analysis identified residue in the motor gear train.Analysis identified wearing on the upper shaft of gear number two.Medtronic developed a design change to reduce motor shaft wear and received regulatory approval for the change.Medtronic began distributing pumps with this design change in august 2017.The returned catheter was subjected to a series of standard tests that include but is not limited to visual inspection, patency testing, and pressure testing.The catheter was returned in 1 segment and no anomalies were noted on microscopic inspection, the catheter was patent, and passed pressure leak testing.(b)(4).If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8555775
• MDR Text Key: 143262405
• Report Number: 3004209178-2019-08400
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/28/2013
• 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