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); Pumping Stopped (1503); Inappropriate or Unexpected Reset (2959)

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

Event Date 06/11/2017

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Information was received from a consumer via a manufacturer's representative regarding a patient who was receiving 500 mcg/ ml of ga blofen at 107.27 mcg/day through flex dosing and 500 mcg/ml of lioresal at 24 mcg to 50 mcg/ day through sc via an implantable pump for intractable spasticity and multiple sclerosis.On (b)(6) 2017, it was reported that the patient's pump showed five low battery resets on (b)(6) 2017.The first occurred at 02:32, then 02:33, then 02:34, 02:35, and 02:46.Tube set was seen on (b)(6) 2017.It was confirmed that the pump alarm was heard.The patient's pump was replaced on (b)(6)2017 and would be returned for analysis.A back table prime of 0.3 mls was performed on the new pump with the intrathecal dosage adjusted accordingly per the doctor's orders.No symptoms were reported.Additional information was received on (b)(6) 2017 from the patient's health care provider (hcp).It was reported that no motor stalls had occurred per the pump logs.The cause of the tube set was unknown.It was also reported that the cause of the low battery reset was unknown as telemetry from the patient's refill on (b)(6) 2017 gave the eri (elective replacement indicator) at 7 months and the battery failed on (b)(6) 2017.The patient's weight was also provided.No further complications were reported.

Manufacturer Narrative

Updated to reflect the information received on 2017-jul-14 if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 2017-jul-14 from the manufacturer's representative (rep).It was reported that the pump would be returned by the facility and, at this time, the rep did not have any information on when it would be returned.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare provider via a company representative.A terminal event was noted as having occurred in the pump.The patient was without injury and had recovered without sequela following device explant.The pump was returned to the manufacturer for analysis.As per the pump¿s log end of service (eos), reset, and elective replacement indicator (eri) occurred.The logs showed multiple low battery resets occurred on (b)(6) 2017 from 02:32 to 02:46 and a stopped pump period may exceed tube set message occurred on (b)(6) 2017 at 02:02.Also per the pumps log, gablofen with concentration 500 mcg/ml was being administered via a flex dose rate of 107.27 mcg/day as of (b)(6) 2017.

Manufacturer Narrative

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

Manufacturer Narrative

The pump was returned, and analysis found high resistance in the battery.(b)(4).Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected (b)(4) because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event.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: 6687189
• MDR Text Key: 79090553
• Report Number: 3004209178-2017-14243
• 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: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2011
• 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: 61 YR
• Patient Weight: 64