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

Model Number 97714

Device Problems Energy Output To Patient Tissue Incorrect (1209); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

The patient had surgery last friday, on wednesday before her surgery, she turned her group b settings down to 0v.Adaptive stim was in group b.The patient was using her therapy on group c from wednesday to friday at 2.5v.On friday before surgery, the patient turned group c settings down to 0v and turned her implantable neurostimulator (ins) off.When the patient got out of the surgery on friday, she turned on her patient programmer (pp) and realized that her therapy was on, not off and was on 2.5v in group c.The device was on the setting the patient had it on before she turned it down and off.Patient then check her group b and it was back to 3.1v, upright position even though she turned the group b down to 0v on wednesday.Group c was not an adaptive group.The patient had no problems and did not notice any interference but wondered why it happened and wanted to know what she needs to do next time she has her second cataract surgery.The patient was asked if she confirmed the ins was off last time she turned it off, patient responded, she pushed the middle button on the left side of the pp but it was dark in the room and hard to see so she did not confirm if pp screen showed the ins was off.The patient¿s health care provider (hcp) confirmed that the patient recovered without permanent impairment.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant products: product id: 97754, serial# (b)(4), product type: recharger.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a160, 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: 4470978
• MDR Text Key: 5182578
• Report Number: 3004209178-2015-01513
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2015
• Date Device Manufactured: 05/29/2014
• 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: 00070 YR