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); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/02/2017

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a device manufacturer representative (rep) regarding a patient who was receiving 2000 mcg/ml gablofen at 605 mcg/day via an implantable pump for intractable spasticity and head/brain injury.It was reported that a premature eri occurred.When the pump was interrogated on 2016-nov-09, the estimated eri was 12 months.However, when the pump was interrogated on 2017-mar-08, it was noted that eri had occurred on (b)(6) 2017 with an eos of (b)(6) 2017 no actions or interventions had taken place, however it was noted the pump would be replaced.The issue was considered to be unresolved and the patient was "alive - no injury".No symptoms were reported.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Additional information was received from a healthcare provider via a company representative.The device system (pump and catheter) were replaced on (b)(6) 2017.The pump was noted as having administered lioresal with concentration 2000 mcg/ml at a dose rate of 603 mcg/day.The patient was not in a clinical study.The explanted devices were returned to the manufacturer for analysis.

Manufacturer Narrative

Information references applicable components of the system and the main component is as follows: product id: 8709, serial# (b)(4), implanted: (b)(6) 2005, explanted: (b)(6) 2017, product type: catheter.The pump and catheter were returned for analysis.Analysis of the pump on (b)(6) 2016 revealed a low battery reset of an undetermined cause.As per the pump¿s log, lioresal with concentration 2,000.0 mcg/ml was being administered at a minimum dose rate of 11.9 mcg/day as of (b)(6) 2017.The catheter was returned in one segment.Analysis of the catheter (model 8709) revealed a user related hole in the catheter body.Analysis noted that a leak was identified in the laboratory regarding the user related hole which was approximately 8 cm from the pin connector.The previously applied results code and conclusion code are no longer applicable.The device code applies to the catheter.The method code applies to the catheter only.The conclusion code is regarding the pump and the conclusion code is regarding the catheter.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event.Medtronic.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.

Manufacturer Narrative

The analysis finding code was updated to be voltage related eri (elective replacement indicator) or eos (end of service) with an undetermined root cause.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.

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6395305
• MDR Text Key: 69607251
• Report Number: 3004209178-2017-05411
• 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,Followup,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2010
• 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: 25 YR