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

Model Number 97713

Device Problem Degraded (1153)

Patient Problem Discomfort (2330)

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received about a patient with an implantable neurostimulator (ins) for chronic low back pain and spinal pain.It was reported that the patient¿s device had gradually become ¿caustic¿ and uncomfortable.The patient stated that they could not use their device at night anymore when they needed it most because it had gotten worse.A list of physicians in the patient¿s area were provided to the patient so they could have their device adjusted as it was reported that the patient lived in (b)(6) for the winters.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient.It was reported programming adjustments were made on (b)(6) 2017.Currently, the issue of the device gradually becoming caustic and uncomfortable had been resolved.However, the patient noted that over time, new adjustments will be needed and that is just the way it works.The issue of the device becoming caustic and uncomfortable happens as time goes by.No further complications were anticipated/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: 6396893
• MDR Text Key: 69742328
• Report Number: 3004209178-2017-05446
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2015
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/17/2017
• Date Device Manufactured: 05/27/2014
• 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: 66 YR