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

Model Number 8637-40

Device Problems Failure to Interrogate (1332); Migration or Expulsion of Device (1395); Unstable (1667); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2018

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 foreign healthcare professional (hcp) regarding a patient receiving intrathecal lioresal 500 mcg/ml at 39.94 mcg/day via an implantable pump.The indication for use was not reported.It was reported the patient went to the hcp¿s office for a follow-up check and some programming.The hcp was unable to establish telemetry to the pump despite using a couple 8840 programmers.They switched rooms and attempted telemetry but remained unsuccessful.It was noted that the pump was a little deeper and hard to palpate.The patient was undergoing an x-ray to rule out a flipped pump.The hcp was awaiting films for review.There were no reported symptoms.No further complications were reported.

Manufacturer Narrative

H6 device codes c62809 and c62955 no longer applies to the event.Conclusion code 92 was updated to 67.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a manufacturer representative (confirmed via healthcare provider following operation) indicated x-rays performed confirmed the pump flipped.The health care provider (hcp) did not share a suspected cause.The correction operation took place (b)(6) 2018.As of (b)(6) -2018, the issue was considered resolved.

Manufacturer Narrative

Corrected information.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: 7660298
• MDR Text Key: 113182777
• Report Number: 3004209178-2018-14967
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 07/12/2018; 08/08/2018
• Supplement Dates FDA Received: 07/13/2018; 10/05/2018
• Date Device Manufactured: 12/22/2017
• 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