MAUDE Adverse Event Report: MEDTRONIC 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 02/20/2018

Event Type  Injury  

Manufacturer Narrative

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 device manufacturer representative regarding a patient who was receiving morphine (10 mg/ml at 3. 629 mg/day) via an implantable infusion pump for non-malignant pain and degenerative disc disease. It was reported that the patient was seen on (b)(6) 2018 for a refill, and at that time the elective replacement indicator (eri) was 37 months. That evening, the pump was alarming. On (b)(6) 2018, the pump was reviewed and showed that eri had occurred. Premature eri was discussed. If the pump were to be replaced, sending the pump back to the manufacturer for analysis was discussed. No patient symptoms were reported. No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep). The pump was replaced on (b)(6) 2018 and would be sent back for analysis. No further issues were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received, indicating that the cause of the premature eri was not determined. A replacement pump was requested. The premature eri was not resolved. The eri was reportedly at (b)(6) 2018. The pump was going to be explanted and sent to the manufacturer. No further complications were reported.

Manufacturer Narrative

The pump was returned, and analysis found a feedthrough anomaly with shorting across the insulator. Recent fda coding changes offer limited options for medical device evaluation conclusion coding. Medtronic selected conclusion code because, although the device meets design specification, corrective actions are focused on 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.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7296068
• MDR Text Key: 100932608
• Report Number: 3004209178-2018-03927
• 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

• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/14/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2014
• 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-1579-2013

Patient Treatment Data

Date Received: 02/26/2018 Patient Sequence Number: 1