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

Model Number 8637-40

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problem Muscular Rigidity (1968)

Event Date 04/30/2017

Event Type  Injury  

Event Description

On 2017-may-02, information was received from a foreign healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was receiving baclofen (unknown dose and concentration) via an implantable pump for an unknown indication.On (b)(6) 2017, the patient's pump began to critically alarm and the patient went to the emergency clinic for examination.The patient experienced increased spasticity.It was reported that elective replacement indicator (eri) occurred earlier than expected.There were no known environmental, external or patient factors that could have contributed to the issue.The nurse who met the patient attempted to solve the problem by refilling the pump.A pump refill occurred as an intervention.It was reported that the pump alarm was turned off and the pump was still working as the rep "understood it".Surgical intervention was planned but has not been scheduled.The patient's status was listed as "alive - no injury".The issue was not resolved at the time of this event.

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

On 2017-may-30, additional information was received from a foreign manufacturer representative (rep).Additional information reported the patient was receiving baclofen (3000 mcg/ml at a dose of 885 mcg/day).Additional information reported the patient heard a critical alarm and this is what caused the patient to contact the emergency room.The "critical alarm said that the pump must be replaced".An inquiry for the cause of the alarm was made and for logs to be obtained, however, the rep reported, "no available logs but the alarm was about short eri".The pump would be replaced on (b)(6).The patient is fine and having a normal daily life.The pump still seemed to work.The remaining eri was 18 months.

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: 6557495
• MDR Text Key: 74838509
• Report Number: 3004209178-2017-10031
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2017
• Date Device Manufactured: 02/16/2011
• 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