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

Model Number 8637-20

Device Problem Premature Elective Replacement Indicator (1483)

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

Event Date 07/28/2017

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 foreign healthcare provider (hcp) via a manufacturer's representative regarding a patient who was receiving baclofen (2000 mcg/ml at 218.1 mcg/day) via an implantable pump for an unknown indication for use.It was reported there was a suspected early elective replacement indicator (eri).The event date was provided as (b)(6) 2017.The pump was replaced on the same date.There were no patient symptoms.Contributing factors were unknown.No troubleshooting was performed.The issue was resolved.The patient status was alive, no injury.No further complications were reported or anticipated.

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: neu_unknown_cath, explanted: (b)(6) 2017, product type: catheter.Analysis identified that eri occurred due to time progression, and there was no significant anomaly.Analysis identified the catheter had coring/tearing/cuts in the seal of the sc connector that met leak criteria.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.

Event Description

The representative stated only the pump was explanted and replaced, and the catheter remained implanted so they did not have information regarding the catheter lot number and implant date.However, the pump was returned with a small section of the pump segment.

• 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: 6773793
• MDR Text Key: 82047827
• Report Number: 3004209178-2017-16424
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2011
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2010
• 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