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

Model Number 97714

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

It was discovered about a month ago that the patient¿s ¿leads were in the wrong place¿.It was reported that ¿they redid it yesterday and put the leads in another place¿.The therapy was not working as expected and the patient would like to meet with a company representative for a device check and/or programming.It was confirmed a week later that the patient had paresthesia that was not in the correct location so the lead was revised on (b)(6) 2014 and moved to a different location.The device has not been re-activated yet.The device was activated two days later and the patient was now receiving effective therapy.The patient was happy with the device.

Manufacturer Narrative

Concomitant medical products: product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 39286-65, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

Event Description

Additional information received further described the previously reported issue of stimulation in the wrong location, lead location, and the lead revision.The manufacturer¿s representative (rep) told the patient that the leads were implanted too high in his back.During the trial he had nice results but once the system was implanted he could only get stimulation in his legs and butt and never had stimulation in the correct location.A lead revision was done.The patient stated that the rep.Was the one who told the surgeon which lead to implant and where to place the lead.

• 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 NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 3926443
• MDR Text Key: 4669067
• Report Number: 3004209178-2014-12794
• Device Sequence Number: 1
• Product Code: GZB
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2014
• 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: 02/24/2015
• Date Device Manufactured: 01/29/2014
• 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 Outcome(s): Required Intervention