MAUDE Adverse Event Report: NEURO - VILLALBA VECTRIS SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 977A260

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 06/18/2014

Event Type  Injury  

Event Description

It was reported the patient had a loss of therapeutic effect.It was noted the patient¿s leg started hurting the night prior to call and increasing stimulation was uncomfortable.It was reported the patient¿s left leg pain was returning.It was noted the patient changed groups on the call and had stimulation in the bottom of their leg, but not the top.It was reported the patient preferred their original group.It was noted the patient then felt stimulation in their right leg, but not their left.It was reported the patient¿s recharger belt moved and would not stay on during use.It was noted reprogramming only helped a little with the pain.It was reported if the pain persisted, the patient would have an x-ray and further testing.It was noted the patient had no accidents, trauma, or medical procedures associated with the issue.It was reported one of the leads may have possibly moved.It was noted the pain¿s return was gradual.

Manufacturer Narrative

Concomitant medical products: 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.Product id: a01411002, serial# unknown, product type: recharger.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

Additional information received from the patient reported that one wire had moved and the healthcare provider (hcp) had to remove that wire and left the other wire in there.It was noted that she lived in a private house and would go up and down too much.She would also walk her dog 3 times a day.She had been instructed not to do any housework.

Manufacturer Narrative

(b)(4).

• Brand Name: VECTRIS SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): NEURO - VILLALBA; call box 6001; ceiba norte industrial park; villalba PR 00766
• 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: 3919192
• MDR Text Key: 4666747
• Report Number: 3004209178-2014-12638
• 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,consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/19/2014

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: 03/04/2018
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 07/08/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/07/2015; 12/07/2015
• Date Device Manufactured: 03/04/2014
• 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
• Patient Age: 00047 YR