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

Model Number 8637-20

Device Problems No Audible Alarm (1019); Failure to Interrogate (1332); Inappropriate or Unexpected Reset (2959)

Patient Problems High Blood Pressure/ Hypertension (1908); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Irritability (2421); Shaking/Tremors (2515)

Event Date 11/28/2016

Event Type  Injury  

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.

Event Description

Information was provided by a healthcare provider regarding an implantable intrathecal pump intended to deliver gablofen 2000 mcg/ml at 575 mcg/day, indicated for intractable spasticity and cerebral palsy.It was reported that an alarm not heard/confirmed by telemetry occurred.On (b)(6) 2016, the patient was at two different hospitals due to baclofen withdrawal (hypertension and shaking.) the pump logs showed a reset, a reset-low battery, and safe state occurred.It was stated that at one of the hospital visits, the pump was programmed to the correct infusion rate and the patient¿s withdrawal symptoms improved; the patient was feeling better and the pump was delivering drug.It was noted by the reporting healthcare provider that they were concerned that the other healthcare provider reprogrammed the pump after the resets occurred; the reporting healthcare provider had the patient follow-up with her and the patient was transferred to their facility.At the time of the call, the pump was still infusing at a simple continuous rate, and it was noted that the pump was to be replaced in a couple of hours ((b)(6) 2016).Additional follow-up was received from the healthcare provider on (b)(6) 2016.It was stated that regarding troubleshooting related to the low battery reset, the pump was found in safe mode and the notes said low battery.The cause of the low battery reset could not be determined; the pump started and then said elective replacement indicator (eri) to be 16 months.The issue with the low battery resets and withdrawal (hypertension and shaking) were said to have been resolved by removing the pump.Additional information was received from the healthcare provider on (b)(6) 2016, on the returned product paperwork.It was indicated that the pump contained lioresal (concentration and dosage unknown).It was stated that the patient presented to a community hospital with increased tone, hypertension and irritability.It was indicated that patient experienced a sudden loss of therapy and the pump was replaced due to pump failure- pump in safe mode.The pump was replaced on (b)(6) 2016 and the patient recovered without sequela.It was noted that the pump would not do telemetry and so the healthcare provider could not turn it off.

Manufacturer Narrative

Interrogation of the pump determined it was used to infuse gablofen [2000 mcg/ml] at 575.7 mcg/day.Analysis of the pump revealed high battery resistance.Result code and conclusion code no longer apply.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.

• 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: 6196186
• MDR Text Key: 63058086
• Report Number: 3004209178-2016-27004
• 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: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2017

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: 12/14/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided; 02/03/2017
• Supplement Dates FDA Received: 02/06/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/21/2011
• 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: 13 YR