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

Model Number 97714

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

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Burning Sensation (2146); Complaint, Ill-Defined (2331); Malaise (2359); Ambulation Difficulties (2544)

Event Type  Injury  

Event Description

It was additionally reported that the patient had trouble walking and felt stimulation in chest/stomach.The patient had a constant fever until the implant was removed.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient had her implantable neurostimulator (ins) removed in (b)(6) 2014 because it made her legs very weak and she couldn¿t walk.The patient had pain and constant burning at the ins site.The stimulation vibrated in her stomach so bad that she felt sick all of the time.The patient was still feeling a false sense of stimulation and her knees felt like they had arthritis in them at the time of the report.The patient had the symptoms since implant and they got progressively worse over time.There was a 50% or greater symptom reduction.There were no reports per the healthcare provider (hcp).The patient was seen (b)(6) 2013 and reported 100% relief of pain.¿ on (b)(6) 2014, now had reversal of vasomotor changes from crps¿.The hcp was not notified of any problems and the patient never followed up.The cause of the event was not determined and unknown if device related.

Manufacturer Narrative

Concomitant 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) 2014, 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: 4243530
• MDR Text Key: 5728441
• Report Number: 3004209178-2014-21321
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2015
• Date Device Manufactured: 11/20/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 00038 YR