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

Model Number 97714

Device Problems Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Battery Problem (2885); Communication or Transmission Problem (2896); Positioning Problem (3009)

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

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 manufacture representative regarding a patient implanted with an implantable neurostimulator (ins).It was reported that the patient's ins was in overdischarge and that the rep conducted 3 physician mode recharges (pmr) with no successful communication with the ins recharger.The rep was advised to conduct an addition pmr session.The rep noted that the ins 'felt normal' in the pocket but that the patient stated that it often protrudes more that it was the day of the call.It was suggested that x-rays be taken of the pocket/lead site to asses ins orientation for a possible flip.The rep stated that there was no fall, weight change or other triggering events that might have led to ins protrusion.The patient had an mri scheduled the week of (b)(6) 2018.No patient complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was reported that the patient is going to get their ins replaced and possibly their lead.No further information was reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the rep reported that the ins was replaced on (b)(6) 2018 the ins was to be returned for analysis.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the rep reported that the ins was replaced on (b)(6) 2018.The ins was to be returned for analysis.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 7590697
• MDR Text Key: 110717736
• Report Number: 3004209178-2018-13147
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/04/2018

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: 08/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 07/05/2018; 07/16/2018; 08/31/2018; 08/08/2018
• Supplement Dates FDA Received: 07/16/2018; 07/23/2018; 09/07/2018; 10/04/2018
• Date Device Manufactured: 09/25/2015
• 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