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

Model Number 8637-40

Device Problem Premature Elective Replacement Indicator (1483)

Patient Problems Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2018

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 professional (hcp) and a patient regarding their implantable drug infusion device. The drug being delivered was 7,000 mcg/ml baclofen (unknown) at 250 mcg/day and updated to 275. 29 mcg/day. The reason for use was non-malignant pain. It was reported that there was an alarm due to eri (elective replacement indicator) on (b)(6) 2018. An alarm was heard and it was confirmed by telemetry that eri occurred. The caller stated estimated eos (end of service) will occur on (b)(6) 2018 according to the logs. There was no low reservoir or eri expected. The pump was only implanted in 2015, so it has only been about 3 years since implant which is unusual. During the call, they reviewed troubleshooting considerations of checking the pump logs, to consider checking programming for accuracy, and to consider replacing the pump. Actions taken as a result of the call were that the caller was redirected to follow up with the hcp to review the considerations. The caller stated she will follow up with the managing hcp and get a hold of the previous reports and see if this eri had been predicted or to see if there has been any programming errors. The caller also stated she will call the manufacturer back for further assistance. There were no symptoms reported. The patient stated he will be ¿very unhappy if the pump needs to be replaced already since it has only been about 3 years since implant. ¿ the pump ¿has not been running more than 1 cc per day. ¿ there were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient via a manufacturer¿s representative (rep) on 2018-aug-23. It was reported that the patient is aggravated because this is the "second pump that has had premature eri. " the patient wants to know what the next steps are. It was confirmed that this pump contains a battery that is not affected by the battery performance communication. It was reviewed a feed through short as consideration for the premature eri. Technical services (ts) investigated the reason for the first pump being replaced, and explained to the caller that the first pump was replaced due to volume discrepancies, not premature eri. Ts informed the rep that the analysis letter for the first pump will be sent to her to confirm this information. The rep mentioned that they plan to send the previous reports to the manufacturer. The rep stated the eri dates had not been changing when they should have during refills. Ts reviewed to have the pump replaced and sent back to the manufacturer for analysis. The rep will follow up with the hcp for next steps. There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer¿s representative (rep) on 2018-sep-16. The patient is now starting to hear their pump critically alarm today (b)(6) 2018). There are no return of symptoms at this time. They already have it planned to replace the pump on (b)(6) 2018, however they might try to move the replacement date up sooner. There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer¿s representative (rep) on (b)(6) 2018. The caller received a text from the patient that the pump is still alarming, and symptoms have returned severely today ((b)(6) 2018). The rep stated that the pump is being replaced tomorrow morning ((b)(6) 2018). There were no further complications reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a patient via manufacturer representative (rep). It was reported that patient was experiencing increase spasticity. No known internal or external factors to contribute to elective replacement indictor (eri) were reported. Pump was replaced with another manufacturer pump- existing catheter. Explanted pump would be returned. At the time of this report, the issue had been resolved and patient status was alive- no injury. 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 the manufacturer¿s representative (rep) on (b)(4) 2018. The caller received a text from the patient that they heard their pump alarm, 5 critical and one non-critical alarm today ((b)(6) 2018). Times were 204, 214, 224, 234, 244 and 248 was the non-critical alarm time. It was unknown if those times were in the a. M. Or p. M. Time frame. The patient had not been seen by the hcp since hearing the alarms today so the caller did not know the indications of the alarms. There were no further complications reported/anticipated.

Manufacturer Narrative

Destructive analysis identified electrochemical migration shorting across the electrical feed-through insulator. If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction - 'adverse event and product problem' is now appropriately selected. 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7805244
• MDR Text Key: 119686591
• Report Number: 3004209178-2018-18857
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• 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-1579-2013

Patient Treatment Data

Date Received: 08/22/2018 Patient Sequence Number: 1