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

Model Number 97714

Device Problems No Device Output (1435); Improper or Incorrect Procedure or Method (2017); Battery Problem (2885)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2021

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 (pt) regarding an implantable neurostimulator (ins).The reason for call was pt mentioned their ins had depleted and would not turn on again a few weeks ago.Pt wanted to get in contact with a mdt rep for an upcoming ins replacement consultation with an hcp named (b)(6) scheduled for (b)(6) 2021.Pt did not know whether or not pt needed a mdt rep for the consultation meeting or the replacement surgery.The patient was redirected to their healthcare provider to have hcp contact the national answering service to get in contact with a mdt rep.Pt mentioned having a hernia surgery last year, 2020.Pt mentioned having 2-3 overdischarge events, but was unsure the date these events occurred.(pt said maybe sometime in 2020, but unsure).Overdischarge events led to the expected ins replacement.Patient services specialist documenting reported event.Pt mentioned ins was depleting quicker, starting about a year ago.Pt mentioned charge frequency issues led to overdischarge events.No patient symptoms were reported.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11879050
• MDR Text Key: 265798318
• Report Number: 3004209178-2021-08295
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2021
• Date Device Manufactured: 01/22/2015
• 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: 36 YR