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

Model Number 97714

Device Problems Unintended Collision (1429); Charging Problem (2892)

Patient Problems Pain (1994); Injury (2348)

Event Date 10/01/2017

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 friend/family member of a patient with an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the patient wanted to get in touch with a manufacturer representative because they had forgotten how to charge their ins.It was reported that the last time the patient had charged was four months ago.It was reported that the patient realized that they couldn't charge about three months ago.It was also reported that the patient was in a lot of pain and was taking tramadol, which makes the patient drowsy.No further complications are anticipated.Additional information was received from a consumer.It was reported that the patient has been in pain since (b)(6) 2017.The patient has been lying in bed taking tramadol and other pain medications because they have not been able to charge their implant for over 4 months, and the ins had possibly gone into overdischarge in (b)(6) 2017.The caller stated they had gone online to find out how to resolve the overdischarge issue.They were redirected to the doctor to resolve the overdischarge.They stated the doctor had redirected them to contact a manufacturer representative (rep).An email was sent to the rep to inform them of the issue.A rep responded stating they would be meeting with the patient at the doctor's office.No further complications were reported or anticipated.Additional information was received from the manufacturer representative.It was reported that the patient had scheduled an appointment, but had to cancel because they had a fall injury.No further complications are anticipated.

• 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: 7430515
• MDR Text Key: 105530237
• Report Number: 3004209178-2018-08027
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/11/2018
• Date Device Manufactured: 08/12/2016
• 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: 70 YR