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

Model Number 8637-40

Device Problems Premature End-of-Life Indicator (1480); Premature Elective Replacement Indicator (1483)

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

Event Date 09/17/2017

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 healthcare professional (hcp) via manufacturer representative (rep) regarding a patient who was receiving baclofen (concentration of 2000mcg/ml at a dose of 711.5 mcg/day) via intrathecal drug delivery pump for intractable spasticity and stroke.It was reported that a pump alarm was heard and confirmed by telemetry.The critical alarm occurred due to end of service (eos) (sr) and estimated replacement indicator (eri) occurred.The eri occurred on (b)(6) 2017 and the eos occurred on (b)(6) 2017.It was reported that the eos was expected to occur on (b)(6) 2017 but instead had prematurely occurred.The patient went to the hospital when they heard the pump critical alarm.The pump logs were checked.Technical services reviewed that the pump had premature eos and reviewed that the pump was included in the population of devices that could potentially be affected by the battery performance field action.The rep reported that they were there to replace the pump on this report date, the rep would review considerations with the healthcare professional.No patient symptoms were reported.No further complications were anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare professional (hcp).It was reported that the pump was explanted and would be returned to the manufacturer; the cause of the premature end of service (eos) was unknown at the time of this report and the hcp was awaiting analysis.The pump was surgically replaced on (b)(6)2017, and the premature eos was resolved.The expected elective replacement interval (eri) was 2017-dec.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received, indicating that the device was explanted as a result of this event, and was returned to the manufacturer for analysis.The cause of the premature eos was a faulty battery.The premature eos was resolved.No further complications were reported.

• 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: 6928602
• MDR Text Key: 88848521
• Report Number: 3004209178-2017-21322
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2018

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: 07/28/2012
• 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: 09/19/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 11/29/2017; 02/09/2018
• Supplement Dates FDA Received: 12/01/2017; 02/13/2018
• Date Device Manufactured: 02/02/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 73