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); Inappropriate or Unexpected Reset (2959)

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

Event Date 08/27/2017

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 healthcare provider (hcp) via a manufacturing representative regarding a patient receiving intrathecal gablofen 2000 mcg/ml at 450 mcg/day via an implantable pump for intractable spasticity and other spasticity.It was reported that elective replacement indicator (eri) was 12 months when the patient was last seen on (b)(6) 2017 for a refill.The logs were read on (b)(6) 2017 after the patient heard an alarm.The logs showed premature battery alarm went off on (b)(6) 2017, putting the pump into safe state.Premature elective replacement indicator (eri) was noted.It was clarified that the premature battery/eri alarm was actually a reference to a low battery reset (followed by safe state).The patient was seen on (b)(6) 2017 and given a prescription for oral baclofen.The patient was educated on withdrawal symptoms, and he did not have withdrawal symptoms at the time.A referral was made to a surgeon for early pump replacement.Surgical intervention had not occurred, and it was unknown if surgical intervention was planned.The issue was not resolved.However, it was noted that the patient¿s status was alive ¿ no injury.It was noted that the patient¿s serial number was ¿included in the field action¿.There were no applicable environmental/external/patient factors that may have led or contributed to the issue.The patient¿s weight was unknown/unavailable.The patient¿s medical history was unavailable.There were no further complications reported.

Manufacturer Narrative

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

Manufacturer Narrative

Updated to reflect the report that the pump was replaced on (b)(6) 2017 b2: updated to reflect the report that the pump was replaced on (b)(6) 2017 updated to reflect the information received on sep-15 2017 updated to reflect the report that the pump was replaced on (b)(6) 2017 updated to reflect the information that the pump was replaced at the reported facility updated to reflect the report that the pump was replaced on (b)(6) 2017 if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer's representative (rep) on 2017-sep-15.It was reported that the patient's pump was replaced on (b)(6) 2017.The new pump serial number was provided and it was reported that the new pump was restarted on 500 mcg/ml of lioresal at 50 mcg/day.The surgeon who performed the replacement and the facility where the replacement took place was provided.It was reported that the manufacturer's representative had the pump in their possession and would be returning it for analysis.The ups tracking number for the replaced pump was provided.No further complications were reported.

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

Event Description

Additional information was received from the rep on 2017-sep-15.It was reported that the pump was returned to the manufacturer for analysis.The pump logs showed that 2,000 mcg/ml baclofen was being delivered at 12.2 mcg/day.It also showed on (b)(6) 2017, eri occurred at 20:59, a reset occurred at 20:59, a low battery reset occurred at 20:59, the pump was in safe state at 20:59, a reset occurred at 21:00, and a low battery reset occurred at 21:00.There were no further complications reported/anticipated.

Manufacturer Narrative

Analysis of the pump found battery high resistance.The pump was included in the potential battery performance population.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: 6834532
• MDR Text Key: 84173224
• Report Number: 3004209178-2017-18507
• 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: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• 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: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2011
• 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: 35 YR