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

Model Number 97702

Device Problems Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2018

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 patient with an implantable neurostimulator (ins) for multiple back operations.The patient indicate d that maybe a week ago there was an elective replacement indicator (eri) on their ins.They looked up the eri code and saw that it meant that the ins is going out.Patient services reviewed eri considerations.There was an allegation against the ins longevity.The patient was not sure if they want to get another non-rechargeable device if the ins will only last 2 years.The patient inquired if their next device will only last 2 years like their current device.The patient relies on their device and is not sure they can rely on another device moving forward.The patient was redirected to follow up with their healthcare professional (hcp) to discuss their options.There were no patient symptoms reported and no complications reported.

Manufacturer Narrative

Product id 3998, lot# j0443868v, implanted: (b)(6) 2004.Product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.They stated that they had the device explanted on (b)(6) 2018 because it was not working and they had a few problems with the unit.They stated at the office in july, the machine was showing a warning and a manufacturer representative (rep) had stated the ins was going out and the leads had gone out; only 4 of the 16 contacts were working.No further patient complications were reported as a result of this event.A rep was contacted who stated they were not aware of this event.No further patient complications were reported asa result of this event.

• 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: 7575271
• MDR Text Key: 110340636
• Report Number: 3004209178-2018-12779
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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,Followup
• Report Date: 09/14/2018

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: 06/28/2017
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 08/22/2018
• Supplement Dates FDA Received: 09/14/2018
• Date Device Manufactured: 12/30/2015
• 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): Required Intervention
• Patient Age: 67 YR