MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Shelf Life Exceeded (1567); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/04/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare provider (hcp) via a manufacturer representative regarding a patient who received an unknown drug in an implantable pump for an unknown indication for use.The pump was replaced on (b)(6) 2017 for an unknown reason.It was indicated the patient was hospitalized.No patient symptoms were reported.No further information was reported.

Manufacturer Narrative

The outcome attributed of hospitalization and intervention required no longer apply to the event.Implant date: estimated; only reported implant year of 2012.Correction: the initial mdr was filed as (b)(4).Additional review showed the correct manufacturing site was (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (confirmed via the hcp) indicated there was no suspected pump issue.The pump was replaced due to battery exhaustion.The issue began two months prior to pump interrogation.An elective replacement indicator (eri) alarm occurred and two months of battery life were left at that time.The hcp requested the "health service" to change the pump.The patient did not experience any symptoms.The pump was used to deliver unknown morphine (10 mg/ml, 6.9 mg/day).The previously reported patient hospitalization was not considered related to the device or therapy.The explanted pump would not be returned to the manufacturer.It was noted the pump was implanted in 2012.No complications were reported/anticipated.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6737732
• MDR Text Key: 80857713
• Report Number: 3007566237-2017-03001
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2010
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2017
• Date Device Manufactured: 07/01/2009
• 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): Hospitalization; Required Intervention