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); Device Operates Differently Than Expected (2913)

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

Event Date 02/27/2017

Event Type  malfunction  

Event Description

Information was received from a consumer regarding a patient receiving intrathecal baclofen 2000 mcg/ml at an unknown dose via an implantable pump for intractable spasticity and cerebral palsy.It was reported that the patient had the pump refilled and went in every 6 weeks for a refill.During the pump refill on (b)(6) 2017, the telemetry printout stated that elective replacement indicator (eri) had occurred on (b)(6) 2017 and end of service (eos) would occur on (b)(6) 2017.The consumer¿s question was based on a reply by the healthcare provider (hcp) that the pump would slow down and not deliver quite as much but keep working.The consumer felt that ¿based on his electrical background, there was something else occurring that was not linear based.¿ the consumer wanted to understand it further and intervene quickly to prevent any pump failure before the pump was replaced.The consumer knew the patient was at a fairly high dosage rate but did not feel the estimated eri should have dropped this much in 6 weeks.At the patient¿s refill 6 weeks ago (from (b)(6) 2017), the printout stated the estimated eri was 13 months.The consumer was going to follow up with the hcp.The consumer know wanted to know if the patient went back in 2 or 4 weeks from now, would ¿it¿ say that things were worse.There were no medical symptoms reported.No further complications were reported or anticipated.

Manufacturer Narrative

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6406981
• MDR Text Key: 70085264
• Report Number: 3004209178-2017-05654
• 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: consumer
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/13/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: 03/13/2017
• Supplement Dates FDA Received: 10/02/2017
• Date Device Manufactured: 02/25/2011
• 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 Age: 24 YR