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 Muscular Rigidity (1968)

Event Date 05/09/2017

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

On 2017-may-15, information was received from a foreign healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was receiving lioresal (3,000 mcg/ml at a dose of 389.7 mcg/day) via an implantable pump programmed to simple continuous for herediatory spastic paraparesis on (b)(6) 2017, a critical alarm occurred due to battery failure.The patient noticed the critical alarm and contacted a nurse at their refill unit immediately.There was no increase in spasticity noted at this time and no other symptoms present.The patient came into the hospital a few hours later and the pump was interrogated by the healthcare professional (hcp).Interrogation indicated eri low battery alarm and the pump was in safe state.The patient was admitted to the inpatient ward and oral baclofen substitution with 20 mg every four hours was initiated.There was a slight increase of spasticity during the following night and day ((b)(6) 2017), but no extra baclofen was needed.The patient was accepted for neurosurgical intervention and operated with explantation of the defect pump and implantation of a new pump on (b)(6) 2017.It was noted, this same day, the patient had a refill of the pump and programming was changed from simplecontinuous to periodic boluses.The patient's status was listed as alive - no injury.The initial reported stated "spasticity when motor stall".This was clarified to be, "critical alarm due to battery failure.Pump in safe state." no further complications were reported/anticipated.

Manufacturer Narrative

Analysis revealed the pump battery had high resistance.(b)(4) no longer applies to this event.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.

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: 6623938
• MDR Text Key: 77231501
• Report Number: 3004209178-2017-11951
• 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: 07/19/2017

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: 08/28/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2017
• Initial Date FDA Received: 06/08/2017
• Supplement Dates Manufacturer Received: 07/18/2017; 07/18/2017
• Supplement Dates FDA Received: 07/19/2017; 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2011
• 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): Hospitalization; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 90