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

Model Number 97714

Device Problems Unintended Collision (1429); Improper Device Output (2953)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 10/01/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for non-malignant pain.Information was reported that the reason the patient called was to have her spinal cord stimulator (scs) device turned off.The patient further stated she had back surgery on (b)(6) 2014 which solved her back problems.It was confirmed that this back surgery solved the problem which she was implanted for.The patient further stated it really worked for a long time and then she had a fall.The patient further explained that when she fell she broke some bones in her back ((b)(6) 2016) and the back surgeon did the back surgery and so they turned her device off for the back surgery and it solved the problem.The patient then stated they turned her scs device back on because she was having bladder problems and thought that her scs device would work for the bladder problems, but it did not.The patient stated now the urologist is going to go in and implant a bladder stimulator and she needs the scs device turned off so she can have the bladder ins implanted.The patient confirmed her bladder problems are unrelated to her device or therapy (does not know when her bladder problems started).The patient stated they tried to work with a manufacturing representative (rep) at hospital to try to get the scs device to help with her bladder problem (control her bladder more) but that did not work.The patient also stated last year she tripped on a cane an fell and fractured her pelvic.The patient did not have her programmer with her at the time of the call.The patient will call back to get help in turning her scs device off.No further complications were reported.No additional patient symptoms were reported.

• 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: 7503696
• MDR Text Key: 108282947
• Report Number: 3004209178-2018-10596
• 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: Patient
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/08/2018
• Date Device Manufactured: 10/17/2014
• 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: 81 YR