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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Therapy Delivered to Incorrect Body Area (1508); Device Operates Differently Than Expected (2913)

Patient Problems Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991); Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Event Description

It was reported that a patient had stimulation in the wrong location.It was reported that the patient felt stimulation in her tailbone rather than her right side below the waist.It was stated that stimulation worked last night, but she lay down to go to bed and the stimulation shut off by itself.It was stated that the patient didn¿t feel stimulation all night.It was stated that when she got up the stimulation was too strong.It was stated that she was feeling the stimulation in her tailbone.The patient stated she tried ¿to move the stimulation down¿ and it went off again.

Manufacturer Narrative

Concomitant medical products: product id: 39565-65, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

Additional information received reported, the patient still had concerns regarding their device or therapy, but they were working with their healthcare professional (hcp) or a manufacturing representative.It was noted, the patient had an appointment on 2014 (b)(6)and had an appointment scheduled for 2014 (b)(6).Additional information received reported the patient had been reprogrammed and was getting adequate therapy.

• 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: 3736991
• MDR Text Key: 4275797
• Report Number: 3004209178-2014-05912
• 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,Followup
• Report Date: 03/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2014
• Date Device Manufactured: 01/16/2014
• 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: 00078 YR