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

Model Number 97714

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problems Electric Shock (2554); No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2017

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 3888-45, lot#: va0flp2, implanted: (b)(6) 2014, product type: lead.Product id: 3888-45, lot#: va0flp2, implanted: (b)(6) 2014, product type: lead.Product id: 3887-45, lot#: va0dtax, implanted: (b)(6) 2014, product type: lead.Product id: 3887-45, lot#: v884578, implanted: (b)(6) 2014, product type: lead.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 from a consumer regarding a patient who was implanted with a neurostimulator for spinal pain and lumbar radiculopathy.It was reported that the patient had ¿kinked¿ a lead wire the week prior to the report ((b)(6) 2017).The patient was working with her health care provider.There were no patient symptoms or complications reported.

Event Description

Additional information was received from the patient.The patient reported that the lead "kinked" when they twisted to pick up a book off the floor and they felt a "pop." the patient reported that they felt a jolt of sensations down the left leg and were unable to lay on their back at that time.It was reported that the doctor was going to monitor the patient's medical care and make a determination of what to do based on their medical status.The patient also reported their weight at the time of the event and they did not know the serial number of the lead.

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.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (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: 6482494
• MDR Text Key: 72539946
• Report Number: 3004209178-2017-08073
• Device Sequence Number: 1
• Product Code: GZB
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2017
• Date Device Manufactured: 02/11/2014
• 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: 35 YR
• Patient Weight: 64