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

Model Number 8637-40

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Calcium Deposits/Calcification (1758); Fatigue (1849); Headache (1880); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Complaint, Ill-Defined (2331); Malaise (2359)

Event Date 06/13/2018

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) via a manufacturer¿s representative (rep) regarding a drug infusion device.The device was being used to deliver 25 mcg/ml prialt/ziconotide at 8.8 mcg/day.The reason for use was not reported.It was reported that since the patient had her pump replaced on (b)(6) 2018, she was lower energy following the surgery for about a week (to be expected), then about 10 days ago (prior to the report date of 2018-jul-09) she got a migraine that wouldn¿t go away.About 5 days ago she felt like she might be getting a cold.She also has issues with kidney stones.Yesterday while talking with her daughter on the phone she wasn¿t as responsive as usual, so her daughter called 911.The patient was brought to the icu (intensive care unit) and her managing physician decided to turn the pump to minimum rate to rule out any issues with the pump.The pump was turned back up to her regular dose this morning.Blood pressure was 54/40 when first responders arrived.Following her pump replacement in june she also had to have another surgery for a hematoma that formed in the pump pocket.There were no environmental/external/patient factors that may have led or contributed to the issue.Diagnostics/actions taken included the pump being turned to minimum rate.Surgical intervention did not occur and it was not planned.It was unknown if the issue was resolved at the time of the report, the patient status was listed as ¿alive ¿ no injury.¿ the patient was in the icu and the cause of the injury was unknown.The patient¿s weight was reported.The hcp would have no further information for the manufacturer.There were no further complications report ed/anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).Information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep on 2018-jul-18.It was reported that the cause of the symptoms of getting a cold, migraine, and wasn¿t responsive was unknown, but it was not related to the device/therapy.It was also reported that it was unknown when the kidney stones issue was first noticed, but it was not related to the device/therapy.The cause of the hematoma was not determined, it was noticed within 12 hours after the patient had her pump replaced and it was unknown if the hematoma resolved.The rep did not have any additional information on this patient at this time.As far as they knew ¿she is not having any health issues related to the pump.¿ the information was confirmed with the hcp.There were no further complications reported/anticipated.

• 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: 7679212
• MDR Text Key: 113740805
• Report Number: 3004209178-2018-15535
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 04/02/2018
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 54