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

Model Number 8637-40

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 01/24/2017

Event Type  Injury  

Event Description

Information was received from a healthcare professional (hcp) regarding a patient who was receiving lioresal [2000 mcg/ml] at a dose of 778 mcg/day via an implantable pump for intractable spasticity and cerebral palsy.It was reported on (b)(6) 2017 that a non-critical alarm was heard and confirmed by telemetry to be elective replacement indicator (eri) occurred.It was noted that the patient was in for a refill that day (b)(6) 2017 and the pump logs were checked and the hcp found that the eri occurred on (b)(6) 2017.A session data report from (b)(6) 2017 was reviewed.It was indicated that the drug concentration and dose were the same as currently programmed and that the session data report indicated an eri of 14 months.It was discussed that eri occurring on (b)(6) 2017 was premature.No symptoms were reported.Additional information was received from a consumer via a manufacturer¿s representative on (b)(6) 2017.It was reported that the pump was found to be in eri on (b)(6) 2017 and that the consumer reported it was not expected to be in eri per prior readouts for another 14 months.It was indicated that there were no environmental/external/patient factors that may have led or contributed to the issue and that there were no diagnostics/troubleshooting performed.Surgical intervention occurred on (b)(6) 2017 as the pump was replaced.It was indicated that the representative would be sending the pump back for analysis.At the time of the report the patient status was ¿alive ¿ no injury¿ and the issue was resolved.No further complications were reported or anticipated.The patient¿s medical history included spasticity.The patient weight was asked but unknown.Other medications the patient was taking at the time of the event could not be obtained as they were not available to the manufacturer.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.(b)(4).

Event Description

Additional information was received from the rep on 2017-apr-07.The pump was returned to the manufacturer for analysis.

Manufacturer Narrative

Analysis of the pump found battery high resistance.The pump was included in the potential battery performance population.(b)(4).

Manufacturer Narrative

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

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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6475023
• MDR Text Key: 72190761
• Report Number: 3004209178-2017-07881
• 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,consum
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2011
• 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-2276-2009, Z-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR