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

Model Number 97713

Device Problems Display or Visual Feedback Problem (1184); Charging Problem (2892); Connection Problem (2900); Material Integrity Problem (2978)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

The patient went to recharge yesterday and at first she got the boxes on the bottom and then everything disappeared.The screen with an empty battery and a plug was seen.The recharger was not charging; patient had the recharger plugged in to charge for two hours yesterday but was not seeing the normal recharger charging screen.The patient continues to see the charge the recharger battery screen even when the recharger is plugged in.The green light was displaying on the recharger.The patient is hoping to get replacement equipment quickly, because she is having return of pain; this started last night when she went to the bathroom around 3am and her legs were hurting her.Six days later, the patient reported the replacement desktop charger that was sent last week is having an issue.It keeps falling out when she plugs it in.The desktop charger is not staying plugged in, it keeps falling out.The connector pin broke.The implantable neurostimulator (ins) was not working for the third time.The patient was having an issue recharging the ins, not getting any coupling boxes darkened.During the report the patient lowered antenna, turned dial, and attempted the antenna locate feature; patient was at 44 and got up to 50 but got frustrated someone wouldn¿t come to her home.It was noted the patient uses a walker and has osteoporosis, the implant causes her more stress.Upon return of the recharger, analysis found the complaint unverified.C100.Upon return of the desktop charger, analysis found the cable assembly connector pins broken.C300.Additional information has been requested to find out if any intervention or troubleshooting was required and to obtain the outcome of this event.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant products: product id 37761, serial # (b)(4), product type recharger; product id 97754, serial # (b)(4), product type recharger; product id 97740, serial # (b)(4), product type programmer, patient; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, 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: 4649275
• MDR Text Key: 17933926
• Report Number: 3004209178-2015-05782
• 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: 03/17/2015

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: 06/28/2015
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 04/01/2015
• Date Device Manufactured: 06/12/2014
• 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: 00080 YR