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

Model Number 8637-20

Device Problems Pumping Stopped (1503); Protective Measures Problem (3015)

Patient Problem Pain (1994)

Event Date 08/04/2018

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 provider (hcp) via a device manufacturer representative regarding a patient receiving morphine(1 mg/ml, 0.1 mg/day) via an implantable infusion pump for the treatment of non-malignant pain.It was reported that motor stall was seen at initial interrogation.There were multiple motor stalls and recoveries.Motor stalls first started to occur on (b)(6) 2018.It was confirmed that there was no emi/magnetic sources present.The patient experienced increase in pain which was considered as a sudden change in therapy/symptoms.Additional information was received from the consumer via a device manufacturer representative.It was reported that patient saw code 8478 (safe state in use) on personal therapy manager (ptm).The healthcare provider (hcp) did not plan on changing the pump out shortly.It was reported that the cause of safe state was unknown.Patient's weight was maybe around (b)(6).The surgery was scheduled on (b)(6) 2018.No further complication was reported.

Manufacturer Narrative

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

Event Description

Device was returned by the representative.Based on logs, 15 motor stalls occurred and 15 motor stalls occurred from (b)(6) 2018 at 09:15 to (b)(6) 2018 at 17:08.No further complication was reported.

Manufacturer Narrative

H3: the pump was returned and analysis identified electrochemical migration across the electrical feed-through insulator.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: 7826654
• MDR Text Key: 118560133
• Report Number: 3004209178-2018-19410
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2015
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 64