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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Therapy Delivered to Incorrect Body Area (1508)

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

Event Type  malfunction  

Event Description

It was reported that the patient was not happy with her stimulator.She had worked with a company representative and she could not get stimulation up above her buttocks.The patient needed it up in her back, but she could not get it to go up that far.This had been the case since implant.The patient had worked with last with a company representative about 2 months ago for quite a while.The program stimulated the right or left side when the patient was in bed but it did not resolve the issues.However, the patient reported stimulation stopped shortly after the last programming session.She could not feel any stimulation at all.The patient had not told her company representative or her physician about the loss of stimulation sensation.The patient stated she was ready to have the device removed.The patient was encouraged to discuss the issues with her managing physician.Additional information regarding troubleshooting, interventions and outcome was requested.If received, a follow up report will be sent.

Event Description

Additional information received reported that it was unknown if there was a 50% or greater symptom reduction.The cause of the event was not determined.Reprogramming was needed, troubleshooting or an action taken to resolve the event was ¿rp¿s¿.The patient recovered without permanent impairment.Further follow is being conducted to determine what was meant by ¿rp¿s¿ for actions taken since it was not clear.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Product id: 39565-65, serial# (b)(4), implanted: (b)(6) 2013, product type: lead.(b)(4).

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 4318735
• MDR Text Key: 5131202
• Report Number: 3004209178-2014-23648
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 12/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/07/2015
• Date Device Manufactured: 09/25/2013
• 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: 00076 YR