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 03/02/2017

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 healthcare provider (hcp) via a manufacturing representative regarding a patient receiving intrathecal dilaudid 12 mg/ml at 6.1 mg/day via an implantable pump for non-malignant pain and chronic low back pain.It was reported that a non-critical, elective replacement indicator (eri) alarm occurred on (b)(6) 2017 and was heard/confirmed by telemetry.The patient was last seen on (b)(6) 2017, and the eri was 13 months.Caller states the patient was seen on (b)(6) 2017 due to alarming, and the eri had occurred (b)(6) 2017 with schedule to replace pump by (b)(6) 2017.The manufacturing representative was going to discuss the issue with the hcp.No symptoms were reported.There were no further complications reported or anticipated.

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

Additional information was received from a healthcare provider (hcp) via a manufacturing representative.It was reported that elective replacement indicator (eri) was confirmed on (b)(6) 2017.The patient was last seen prior to the eri on (b)(6) 2017.It was reported that the patient¿s pump replacement was possibly scheduled for (b)(6) 2017.There were no contributing factors to the event.Poor battery performance was noted.It was noted that the patient¿s bmi was 31, and they were 6¿3¿.The patient was referred for replacement, and a manufacturing representative would be present.

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6411486
• MDR Text Key: 70179416
• Report Number: 3004209178-2017-05777
• 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,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2017
• Date Device Manufactured: 05/19/2011
• 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
• Patient Age: 68 YR
• Patient Weight: 114