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

Model Number 8637-20

Device Problems Difficult to Interrogate (1331); Device Displays Incorrect Message (2591); Inappropriate or Unexpected Reset (2959)

Patient Problem Muscular Rigidity (1968)

Event Date 08/07/2017

Event Type  Injury  

Manufacturer Narrative

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 healthcare provider (hcp) regarding a patient who was receiving 2000 mcg/ml gablofen at 571.8 mcg/day via an implantable pump for intractable spasticity and cerebral palsy.It was reported that the patient lived in a clinical setting and the providers heard his pump alarm.The event logs confirmed a low battery reset and safe state occurred on (b)(6) 2017 at 1758.The pump was reprogrammed back to flex mode and the critical alarm was noted to be 10 minutes.The patient currently had no symptoms, however the patient was recently hospitalized for non-pump therapy related issues (pneumonia and fungal infection) and during the hospitalization, it was noted that the patient's spasticity was worse.No further complications were reported.

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 (hcp).The patient first started experiencing the spasticity on (b)(6) 2017.The patient's pump battery depleted early, but eri still showed 7 months.The pump was noted to be alarming and turned on "safe mode" due to low battery.They tried changing it to simple continuous, however within 5 hours the pump was beeping again.The patient was scheduled for a surgical consult for replacement.

Manufacturer Narrative

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

Event Description

Additional information received from the health care professional via the manufacturers representative indicated that the pump was explanted on (b)(6) 2017.The serial number of the clinician programmer that displayed error code 08:08:f9:40-1529(15), invalid telemetry was unknown.The explanted pump was placed in mail but the tracking number was unknown.No further complications were reported.

Manufacturer Narrative

Other applicable components are: product id 8840 serial# unknown product type programmer, physician if information is provided in the future, a supplemental report will be issued.

Event Description

The manufacturers representative indicated that she was sending the pump back for analysis but the pump kept alarming from the low battery, reset, safe state and she saw an (b)(4) invalid telemetry when interrogating the affected pump today.Technical service specialist reviewed and troubleshooted with the rep and the rep was then able to successfully telemetry and update the pump.No further complications were reported.

Manufacturer Narrative

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

Manufacturer Narrative

The pump was returned, and 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: 6777390
• MDR Text Key: 82615237
• Report Number: 3004209178-2017-16521
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2011
• 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): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 55