MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 97714

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problems Chest Pain (1776); Undesired Nerve Stimulation (1980); Respiratory Distress (2045)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Information was received from a patient implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient felt a shock that went from the ins pocket site up the back left shoulder blade, chest/heart area, and left shoulder.The patient's phone was in his shirt pocket and it crackled.The patient had to sit down for two hours after the shock and it took him two days before the pain went away.The caller stated that he felt like it affected his heart.It was noted that the shock happened once.The stimulation change was not reported to have been related to positional movement.The patient was in his living room and went to turn stimulation on when he felt the shock.The patient went to a health care professional on (b)(6) 2016 and they checked him out and everything seemed fine.Additional information has been requested regarding diagnostics and troubleshooting, but it was not available at the time of this report.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.It was reported that the patient couldn't breathe very well so he had to sit and lie down for two hours until he felt that he could stand.It took two days for the pain to go away in the chest/heart area and in the shoulder.The patient was to go for a cortisone shot in his shoulder which still hurt.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5470871
• MDR Text Key: 39424014
• Report Number: 3004209178-2016-03710
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/01/2016
• Date Device Manufactured: 01/21/2016
• 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
• Patient Age: 00050 YR