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

Model Number 8637-40

Device Problems Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)

Patient Problems Low Blood Pressure/ Hypotension (1914); Muscular Rigidity (1968); Cognitive Changes (2551); No Code Available (3191)

Event Date 09/30/2017

Event Type  Injury  

Manufacturer Narrative

"eyes rolling back in her head".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.

Event Description

Information was received from a health care provider (hcp) via a manufacturer representative regarding a patient with an implantable drug infusion pump indicated for intractable spasticity and multiple sclerosis.The pump contained gablofen [2000 mcg/ml] at a dose of 651 mcg/day.It was reported an alarm was heard and confirmed by telemetry.The representative stated the patient was due for a pump replacement, and the pump hit early replacement indicator (eri) on (b)(6) 2017.The schedule to replace by date was (b)(6) 2017.The representative stated that the hcp tried to interrogate the pump on (b)(6) 2017, and it said the pump was in safe state.They ¿couldn't do anything or move on the screen¿.The representative stated the patient was hallucinating, super spastic, eyes rolling back in her head, blood pressure was dropping, and they were sending the patient to the emergency room.It was further reported the patient was seen in the hcps office on (b)(6) 2017 with increased spasticity, decreased blood pressure, and hallucinations.A pump interrogation showed the pump was in safe state since (b)(6) 2017.The dosing had gone from 651 mcg/day down to 12 mcg/day.An ambulance was called, and the patient was transferred to the emergency room.Troubleshooting/diagnostics included checking the pump logs.The patient was admitted to the intensive care unit (icu) on (b)(6) 2017 and was being medically managed until the pump could be replaced on (b)(6) 2017.It was unknown if the issue was resolved at the time of the report.The patient status at the time of the report was alive ¿ no injury.No further patient complications were reported.

Manufacturer Narrative

Updated to reflect the information received on (b)(6) 2017.Updated to reflect the receipt of the pump on (b)(6) 2017.Updated to reflect the report that analysis has not yet been completed on this pump.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the healthcare provider on (b)(6) 2017.It was reported that the patient had a pump check on (b)(6) 2017, another pump check for (b)(6) 2017.It was assumed that the medical symptoms were resolved unless anything new showed up as the patient was coming in for pump checks.No further complications were reported.

Manufacturer Narrative

Updated to reflect the information received on (b)(6)2017.Device codes (b)(4) added to reflect the information received on (b)(6)2017 if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on (b)(6)2017 from the patient's healthcare provider via the manufacturer's representative.It was confirmed that there was a low battery reset message in the pump logs in addition to the safe state message.The patient's eri alarm was confirmed to be normal.Per the hcp, the pump was confirmed to have been replaced on (b)(6)2017.No further complications were reported.

Manufacturer Narrative

Analysis found high resistance in the pump battery.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): 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: 6947807
• MDR Text Key: 89290134
• Report Number: 3004209178-2017-21762
• 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,Followup,Followup
• Report Date: 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2012
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/13/2017
• Supplement Dates Manufacturer Received: 10/13/2017; 11/01/2017; 12/06/2017
• Supplement Dates FDA Received: 10/16/2017; 11/01/2017; 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2011
• 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-3043-2011
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR