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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Premature Elective Replacement Indicator (1483)

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

Event Date 11/11/2016

Event Type  Injury  

Event Description

Information was received regarding a patient receiving clonidine [320 mcg/ml] at a rate of 148.57 mcg/day and morphine [2.8 mg/ml] at a rate of 1.3 mg/day via intrathecal drug delivery pump for non-malignant pain and complex regional pain syndrome type ii.It was reported that the elective replacement indicator (eri) showed 19 months on (b)(6) 2016 and an actual eri occurred on (b)(6) 2016.It was reported that it's possible an end of service (eos) could occur early as well so they should consider replacing the pump as soon as possible.There were no reported symptoms.

Manufacturer Narrative

The type of reportable event has been changed to serious injury to reflect the reported explant (surgical intervention performed).Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.Conclusion code no longer applies.

Event Description

Additional information was received from a healthcare provider via a manufacturer's representative on (b)(6) 2017.It was reported that the pump was replaced on (b)(6) 2017 due to premature elective replacement indicator (eri) lapse.It was stated that eri went from 19 months to 4 months in a 2 month interval.It was stated that there was no patient effect.The provided pump logs show eri occurred on (b)(6) 2016 at 01:23.It was indicated that no patient injury occurred.A dye study was performed and the results were patent.

Manufacturer Narrative

Analysis of the pump found that the pump battery had high resistance.(b)(4).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

Eval code - conclusion code ¿ is being updated for this event.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.

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: 6305684
• MDR Text Key: 66661190
• Report Number: 3004209178-2017-02667
• 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: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2011
• 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: 46 YR