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

Model Number 8637-40

Device Problems Premature Elective Replacement Indicator (1483); Pumping Stopped (1503); Intermittent Infusion (2341)

Patient Problems Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) via a device manufacturer representative (rep) regarding a patient who was receiving 5 mg/ml morphine at an unknown dose via an implantable pump for spinal pain.It was reported that the pump alarmed and showed repeated motor stalls.It was unknown if any external, environmental, or patient factors may have led or contributed to the issue.No diagnostics or troubleshooting was performed and a replacement was scheduled and performed.No symptoms were noted and the patient was considered to be "alive-no injury".The issue was considered to be resolved.The event date was asked, but unknown.

Manufacturer Narrative

Analysis results were not available at the time of this report.A supplemental will be sent when analysis is completed.

Event Description

Additional information was received from a manufacturer's representative.It was reported that a motor stall was seen at the initial interrogation of the pump.It was unknown if the patient recently had a magnetic resonance imaging (mri) session.The motor stall had been active and the stopped pump period may have exceeded tube set.When the healthcare provider interrogated the pump they received an attention dialog box with the following alerts: motor stall occurred, stopped pump period may exceed tube set, eri (elective replacement indicator) occurred.It was stated that the patient had a sudden loss of therapy.The date the event occurred was unknown.It was reported that the patient had the pump replaced on (b)(6) 2017.It was stated the device would be returned to the manufacturer and that the device may be disassembled for destructive analysis.An analysis report was requested.It was stated the patient recovered without sequela.It was stated that no (b)(6) study were performed.

Manufacturer Narrative

Evaluation of implantable pump serial number (b)(4) revealed corrosion and bridging across the feed through insulation.Electrical shorting across the m1 and m2 feed through insulators was observed in the lab during functional testing.Interrogation of the device indicated it was being used to deliver 5 mg/ml of morphine at 0.0312 mg/day in minimum rate mode.Interrogation also revealed the pump was in a safe state, a low battery reset occurred, and a motor stall occurred.(b)(4).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.

Manufacturer Narrative

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.

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6269527
• MDR Text Key: 65502075
• Report Number: 3004209178-2017-01438
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2014
• 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