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

Model Number 97702

Device Problems Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Muscular Rigidity (1968); Device Overstimulation of Tissue (1991); Respiratory Distress (2045); Therapeutic Effects, Unexpected (2099); Twitching (2172)

Event Date 07/01/2015

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id 97740, serial# (b)(4), product type: programmer, patient.Product id 3 708240, serial# (b)(4), implanted: (b)(6) 2015, product type: extension.Product id 3998, lot# va0mffn, implanted: (b)(6) 2015, product type: lead.(b)(4).

Event Description

It was reported that the patient had a change in therapy of overstimulation and stimulation in an undesired/wrong location.This eve nt took place suddenly and one time the day before this report when they were in the sitting position in the bathroom.Their legs started jumping, their stomach started tightening up and they could not breathe.The patient programmer (pp) showed that the device was on; they then turned the device off and they could breathe again.There were no trauma or falls related to the issue.When the patient had left the doctor's office, the device was working good/right and they could feel it going through their legs.The day of this report, the patient turned stimulation on again and it was at 1.8 v; it was working right and they were getting the coverage that they needed, just like when they had left the doctor's office.They had also tried sitting again and this event did not reoccur.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

(b)(4).

Event Description

Additional information reported by the patient noted that the steps taken to resolve the sudden overstimulation was to reduce the stimulation level.The sudden overstimulation had not been resolved like they wanted.When they increased stimulation they were still having problems with it hurting in their rib cage.If additional information is received, a follow-up report will be sent.

• 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: 4936218
• MDR Text Key: 24573621
• Report Number: 3004209178-2015-14003
• 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
• Report Date: 07/02/2015

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: 09/14/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2015
• Date Device Manufactured: 03/27/2015
• 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: 00051 YR