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

Model Number 8637-40

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Type  Injury  

Event Description

It was reported that there were catheter problems that resulted in revision of a pump connector.A dye study was performed, in which a leak around the hub of the connector was discovered; the suture had slipped off the pump connector.Only the pump segment was replaced, as the suture had eroded through the catheter pump connector and slipped off, causing the leak.No inactive pieces were left inside the body, and the device was not explanted.The pump connector was revised and the healthcare provider (hcp) cleared the catheter.No patient symptoms were reported.The catheter was to be re-primed, but they did not know the catheter length.As a result, the hcp decided to keep the pump at a minimum rate and let the managing hcp prime the catheter.The managing hcp estimated the catheter length and programmed a prime.The managing hcp cut the gablofen dose from 381.2 mcg/day to 120 mcg/day.At the time of the event, the pump was being used to deliver gablofen (baclofen).On (b)(6) 2015, the patient was reported to be alive and receiving effective therapy.

Manufacturer Narrative

Concomitant product: product id 8703w, serial # (b)(4), implanted: (b)(6) 1997, product type catheter.(b)(4).

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4850150
• MDR Text Key: 5933362
• Report Number: 3004209178-2015-11732
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/27/2015
• Date Device Manufactured: 05/30/2014
• 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: 00038 YR