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

Model Number 97713

Device Problems Mechanical Problem (1384); Insufficient Information (3190); Data Problem (3196)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97740, serial#: (b)(4), product type: programmer, patient.Other relevant device(s) are: product id: 97740, serial/lot #: (b)(4), udi#: (b)(4).Analysis of the programmer (serial #: (b)(4)) found that the digital boards were corroded and the device was scrapped.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient.It was reported that the programmer was damaged and had gotten wet, as the patient dropped it into a toilet and tried to dry it out.The patient further explained that after they dropped it in the toilet, they started getting a ¿006¿ error code.The patient stated that they later tried to use the programmer, but instead of stimulation going up, it went negative.No out of box failures were reported.The patient was redirected to the repair department and a replacement programmer was requested.No further complications were reported or anticipated.Indication for use is non-malignant pain.

Manufacturer Narrative

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

Event Description

Additional information was received from a patient.It was reported that the issue had resolved.Replacement was sent.No further complications were reported.

Manufacturer Narrative

Concomitant medical products: product id 97740 serial# (b)(4).Product type programmer.

• 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: 8952447
• MDR Text Key: 156582828
• Report Number: 3004209178-2019-16741
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2019
• Date Device Manufactured: 03/16/2015
• 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 Age: 69 YR
• Patient Weight: 91