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 Problems Sepsis (2067); Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)

Event Date 10/03/2017

Event Type  Injury  

Event Description

Information was received from the manufacturers representative and nurse regarding a patient who was receiving clonidine (concentration 127 mcg/ml, dose 22.8 mcg/day) and morphine (concentration 20 mg/ml, dose 3.598 mg/day) via an implantable pump.An alarm was heard and confirmed by telemetry, the critical alarm was due to low battery reset, reset occurred and safe state that occurred on the day prior to this report date.The pump logs were checked during the call.There were no symptoms reported.No further complications were reported.

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 (rep) indicated that an explant occurred as scheduled for october 16, the rep would be sending the pump back to the manufacturer.There was no patient weight information.No further complications were anticipated/reported.

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a consumer via a manufacturer's representative.It was reported that the patient had "other health issues" at the time of explant and due to her being septic, the system had to be removed.No further information was provided.No further complications were anticipated/reported.

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 cause of low battery reset was elective replacement indicator (eri) as it was 2 months premature.Interventions/actions were noted as resetting of dosage and silencing of the alarms.The low battery reset issue had not been resolved as the alarms went off again.A pump replacement was scheduled for (b)(6) 2017, the pump would be returned for analysis.No further complications were anticipated/reported.

Manufacturer Narrative

Correction: updated 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 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: 6922032
• MDR Text Key: 89937038
• Report Number: 3004209178-2017-20921
• 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: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2010
• 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): Life Threatening; Required Intervention
• Patient Age: 67 YR