MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37702

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problems Arrhythmia (1721); Pain (1994)

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (manufacturer representative, foreign) regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the ins was implanted in the patient's left thoracic, just above the heart, and a cervical electrode for pain in his 2 upper limbs.The patient was recently implanted with a st.Jude pacemaker on the thoracic right side. when the patient turns on the ins and/or when he increases stimulation he feels palpitations which disappears when he reduces the intensity.The intensity was already very low (0.65v on one program and 0.25v on the other) but unfortunately his pain reappears then.The action taken to resolve the event was increased the fq from 50 to 100 hz.Per the patient, the event resolved.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; SZ 1131
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11261069
• MDR Text Key: 229837719
• Report Number: 9614453-2021-00374
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/01/2021

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: 10/14/2017
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/01/2021
• Date Device Manufactured: 04/27/2016
• 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