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

Model Number 8637-40

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 10/03/2018

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 foreign healthcare professional (hcp) regarding a patient receiving intrathecal dilaudid 10 mg/ml at 3.4 mg/day via an implantable pump.The indication for use was not reported.It was reported the patient called the hcp stating she was hearing her non-critical alarm every hour.The hcp confirmed that on the last session data report, the critical alarm interval was set to alarm every 10 minutes, and the non-critical alarm was set to alarm every hour.The patient had been hearing the non-critical alarm for 3-4 days (from (b)(6) 2018).The hcp confirmed that last session data report showed the patient's low reservoir alarm was not scheduled to go off until (b)(6) 2018.The hcp confirmed that it could not be the low reservoir alarm because the pump reservoir was updated successfully, and the patient did not have a ptm.At the last refill in (b)(6) 2018, the session data report displayed there was an elective replacement indicator (eri) of 40 months.The patient had been experiencing symptoms of inadequate pain relief for ¿a couple of weeks¿ (from (b)(6) 2018).No further complications were reported.Additional information was received from an hcp via a manufacturer's representative.The cause of the alarm was occurrence of the elective replacement indicator (eri) on (b)(6) 2018.It was indicated the pump was last replaced on (b)(6) 2015.It was reported the logs had been read and nothing abnormal was found; they were not sure of the cause of the inadequate pain relief.It was stated "the pump will (b)(6) 2018, and be sent for analysis".This reasonably suggests the pump would be explanted/replaced on that date.The issue had not yet been resolved.It was stated there was nothing else to report.

Manufacturer Narrative

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

Event Description

Additional information received indicated that the pump had been explanted as of (b)(6) 2018 (exact explant date not provided) and would be returned.It was also reported that it was unknown if the issue was resolved and the patient status was unknown at the time of this report.

Manufacturer Narrative

Analysis of the pump identified a feedthru anomaly; shorting across the insulator was observed.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
• MDR Report Key: 8179724
• MDR Text Key: 130884309
• Report Number: 3004209178-2018-28006
• 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: company representative,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Date Manufacturer Received: 03/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1579-2013
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention