MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO PRIMEADVANCED; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 37702

Device Problems Electromagnetic Interference (1194); Battery Problem (2885)

Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Pain (1994); Dizziness (2194); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for other pain indications ¿ other.The patient reported that the doctor who implanted it wouldn¿t give her control of it and it stopped giving her any pain relief, so she just let the battery die.The patient didn¿t know what else to do.The patient reported that it was not turned on, the battery was dead.The patient reported that she accidentally went through a metal detector last saturday night and it made her feel very odd.The patient reported that her head was buzzing, she felt very dizzy, and her chest around the device hurt.The patient reported that she thought this was very strange because the battery was dead.The patient reported that she was at a concert and the emts hooked her up to a cardiac monitor and everything looked fine, just her blood pressure was a little high.The patient reported that she felt okay now, have just had a headache off and on since then.No further complications were reported.

• Brand Name: PRIMEADVANCED
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 8261521
• MDR Text Key: 133551576
• Report Number: 3004209178-2019-01328
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2008
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2019
• Date Device Manufactured: 11/09/2006
• 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