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

Model Number 8637-40

Device Problems Difficult to Interrogate (1331); Unstable (1667)

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

Event Date 06/14/2016

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8784, serial# (b)(4), implanted: (b)(6) 2015, product type: catheter.Product id: 8780, serial# (b)(4), implanted: (b)(6) 2014, product type: catheter.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 reported by the consumer via a company representative regarding the consumer's implanted device which was used to deliver baclofen (1000 mcg/ml at 425 mcg/day) from an implanted pump.The indication for use was intractable spasticity and cerebral palsy.On 2016-06-16 a confirmed flipped pump was reported; the flipped pump was discovered on (b)(6) 2016 when the patient went in for a refill.A revision was done on (b)(6) 2016 to flip it back and secure it down.No symptoms were reported.Additional information was requested regarding a bridge bolus, as the baclofen concentration was changed from 1000 mcg/ml to 2000 mcg/ml on (b)(6) 2016.Additional information was reported by the rep on 2016-06-29.The rep reported that the pump was no longer anchored in the pocket.Additional information was reported on 2016-07-12.The pump had been replaced due to the flipped pump issue.

Event Description

Additional information was reported by the company representative on 2016-07-12.The rep reported having difficulty getting telemetry in the past.It was noted that the patient had a very sophisticated electric wheelchair that could be a source of electromagnetic interference.

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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5791998
• MDR Text Key: 49462390
• Report Number: 3004209178-2016-14155
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/12/2016
• Date Device Manufactured: 10/16/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR