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

Model Number 8637-20

Device Problems Premature Elective Replacement Indicator (1483); Inappropriate or Unexpected Reset (2959)

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

Event Date 09/24/2017

Event Type  Injury  

Event Description

Information was received from a consumer via a manufacturer representative (rep) regarding a patient who was receiving 1 mg/ml dilaudid at 0.0480 mg/day via an implantable pump for an unknown indication for use.It was reported that the patient's pump started beeping on friday and she went into the clinic.The pump was read and "reset occurred" and "pump in safe state" messages were noted.There were no known environmental, external, or patient factors that may have led or contributed to the issue.No diagnostics or troubleshooting occurred.No actions or interventions were taken aside from replacing the pump and the event was considered to be resolved.The patient was noted to be "alive - no injury" and no symptoms were reported.No further issues were reported or anticipated.

Manufacturer Narrative

The pump was returned, and analysis found resistance in the battery.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.Eval code-conclusion 92 is no longer applicable.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider on november 09, 2017.It was indicated the pump was replaced on (b)(6) 2017.The device was returned to the manufacturer for analysis on (b)(6) 2017.It was indicated the pump had been used with/in the patient for treatment.There was no patient death, and the patient recovered without sequela.It was reported the reason for the device removal was battery depletion.No rotor/dye studies had been performed.Per the device logs, the pump had been examined on (b)(6) 2017, with the last change occurring on (b)(6) 2017.The logs indicated the pump was in safe state, and a reset had occurred.The pump was delivering 1.0 mg/ml of dilaudid at 0.0061 mg/day in minimum rate infusion mode.The elective replacement indicator (eri) was 8 months.The logs indicated an "eri occurred" message on (b)(6) 2017 at 17:39, along with a "reset occurred," "reset occurred - low battery," and "pump in safe state" message at the same time.

• 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: 6961973
• MDR Text Key: 89735274
• Report Number: 3004209178-2017-22148
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2011
• 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
• Patient Age: 71 YR