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

Model Number 8637-40

Device Problem Inappropriate or Unexpected Reset (2959)

Patient Problems Abdominal Pain (1685); Seizures (2063); Therapeutic Response, Decreased (2271); Shaking/Tremors (2515); No Known Impact Or Consequence To Patient (2692)

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 via manufacture representative on (b)(6) 2017 regarding a patient receiving clonidine (350mcg/ml at 17.49mcg/day), bupivacaine (2mg/ml at 0.0999mg/day), and dilaudid (10mg/ml at 0.5mg/day) via an implanted infusion pump.The indication for use was intractable spasticity.It was reported that an alarm was heard or confirmed by telemetry, but there was no mention of an audible alarm.During a refill, the hcp happened to notice that the event logs indicated a low battery reset and safe state had occurred.There were no events showing up in the event logs prior to (b)(6) 2017, and the date of the event was unknown.It was noted that the elective replacement indicator (eri) had 8 months left on the pump, and the patient was being supplemented with oral meds.It was unknown if the patient experienced any symptoms.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider on 2017-nov-07.It was reported that the patient was admitted to the hospital in early october with signs and symptoms of drug withdrawal.The patient was transferred to another hospital and was scanned showing a pump stall, per the nurse who phoned the managing hcp's office.The patient was ordered oral narcotics.The reported symptoms included withdrawal symptoms, seizure/tremors, and abdominal pain.It was noted that at the time of report (2017 (b)(6)), the patient was presently hospitalized for pneumonia and sepsis, and needed to be cleared of infection prior to replacement.

• 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: 6987206
• MDR Text Key: 91297556
• Report Number: 3004209178-2017-22756
• 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
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• 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: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2017
• 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
• Removal/Correction Number: Z-2276-2009, Z-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 84