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

Model Number 8637-20

Device Problems Device Alarm System (1012); Failure to Interrogate (1332); Communication or Transmission Problem (2896)

Patient Problem Pain (1994)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

Analysis results identified a general pump hybrid anomaly.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving 25 mcg/ml clonidine at 6.5 mcg/day, 5 mg/ml bupivacaine at 1.3 mg/day, and 5 mg/ml dilaudid at 1.3 mg/day via an implantable pump for non-malignant pain and chronic low back pain.It was reported that a pump alarm was heard on (b)(6) 2016.The hcp had a programmer, however they were getting an invalid telemetry message.It was noted that the pump was very superficial and easy to touch.The alarm was noted to be constant and almost sounded like the critical alarm playing backwards.It was further noted the patient was experiencing increased pain since one week ago.The physician placed a magnet over the pump for ten minutes in order to stop it, however there was no change.It was stated that they would have a device manufacturer representative (rep) take a look at the pump on (b)(6) 2016 in the clinic.It was further stated that the pump would be replaced if there was no change by (b)(6) 2016.On (b)(6) 2016, the rep was not able to read the pump and the pump was alarming non-stop.The patient had not had any radiation or mri¿s.Technical services recommended that the patient have the pump replaced.It was noted that the patient went to bed one night and woke up on (b)(6) 2016 and their back was in more pain.The patient said that the pump started to alarm on (b)(6) 2016.The pump was explanted due to prophylactic removal to avoid in-vivo battery depletion, and received by the manufacturer for analysis on 2016-nov-08.

Manufacturer Narrative

Regarding analysis, it was confirmed that the pump was constantly alarming and interrogation was not possible.Analysis also confirmed an abnormal alarm occurring.Due to the hybrid issue, telemetry could not be performed.Logs also could not be acquired and standard performance tests could not be performed.The hybrid has been sent for further analysis.A supplemental report will be submitted if/when additional analysis results are available.

Manufacturer Narrative

Additional analysis results were provided.Analysis found.Ump/miscellaneous/abnormal noise confirmed.Product analysis laboratory analysis determined that the reported no telemetry, high current drain (cd), and constant alarming error conditions were caused by a solder bridge short between the xa3 and xa4 signals on the u1 l334 integrated circuit (ic).

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.

Manufacturer Narrative

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): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6114628
• MDR Text Key: 60425644
• Report Number: 3004209178-2016-24383
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 643169100831
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/10/2017

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: 10/28/2015
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 11/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 02/07/2017
• Supplement Dates FDA Received: 12/27/2016; 02/02/2017; 02/10/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2014
• 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): Other; Required Intervention
• Patient Age: 41 YR