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

Model Number 97712

Device Problem Failure to Deliver Energy (1211)

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

Event Type  malfunction  

Event Description

It was reported that the patient¿s device was for headaches, but it was not helping.The leads were in c1 and c2.The patient had 2 programs.When she made adjustments in the programs, she would only feel stimulation on the rightside.When she sat or lay down, she felt stimulation down her right arm and felt jolts down the arm as well.The patient felt nothing on the left side.The patient had the device programmed the day prior, and it was perfect.After she left the programming appointment she started having issues.The patient decreased stimulation and it resolved the painful stimulation in the arm.Guidelines on programmer functions were given, as well as mri compatibility, as the patient was going to have an mri of the lower abdomen, which was stated to be unrelated.Additional information regarding troubleshooting, interventions and outcome was requested.If received, a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id 97740, serial# (b)(4), product type: programmer, patient; product id 97754, serial# (b)(4), product type: recharger; product id 977a290, serial# (b)(4), implanted: (b)(6) 2015, product type: lead; product id 977a290, serial# (b)(4), implanted: (b)(6) 2015, product type: lead.(b)(4).

• 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: 4532231
• MDR Text Key: 17276047
• Report Number: 3004209178-2015-03427
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2015

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: 04/14/2015
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 02/20/2015
• Date Device Manufactured: 05/19/2014
• 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