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

Model Number 97712

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tinnitus (2103); Dysphasia (2195); Complaint, Ill-Defined (2331); Loss of consciousness (2418)

Event Date 06/17/2018

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 consumer regarding an implantable neurostimulator (ins) for the treatment of head/neck non-malignant pain and spinal pain.It was reported that the patient has the device implanted to treat headaches.The patient has leads on both sides of their temple on the front and back.The patient is experiencing a lot of ringing in their ears and they are trying to figure out if it has anything to do with their stimulator.The patient attempted to contact the manufacturer's representative, but hadn't heard back from them.No further complications were reported or anticipated.No device allegations were made.Additional information was received from a consumer.The consumer reported that the patient had been experiencing a high-pitched volume in his head that caused him to be unconscious.The consumer reported that this noise ¿wipes him out mentally.¿ the consumer reported that the patient felt like the device was ringing on the inside of his body.The consumer reported that the patient had slurred speech and stutters.The consumer wanted to know if these issues were caused by the device ¿in his head.¿ the consumer reported that the patient had not had any falls or traumas but has had a significant change in weight loss.The consumer reported that they had shut the device off, but the issues still remained.The consumer noted that the patient was currently experiencing the same issue as he had last year with hearing things and having slurred speech.No further complications were reported.

• 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 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: 9040150
• MDR Text Key: 159514209
• Report Number: 3004209178-2019-17637
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2018
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/10/2019
• Date Device Manufactured: 05/09/2017
• 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): Other
• Patient Age: 54 YR