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

Model Number 97714

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 11/01/2014

Event Type  malfunction  

Event Description

The patient indicated that he still had concerns but was working with his physician.The patient noted an appointment on 2014-(b)(6).In addition, the patient also indicated he still had concerns but had not sought further help.The patient stated he needed continual tuning until it settles in and he thought it was probably his fault.The patient also stated that he had been too mobile and needed to heal.A company representative indicated that the device was reprogrammed and amplitude was turned down.The patient was now getting effective therapy with no shocking.

Event Description

It was reported that the patient experienced a shocking/jolting sensation when trying to use his stimulator several days prior.The patient didn¿t think increasing it could have given him such a shock.The patient stated he was trained after implant, when the condition wasn¿t ideal, and wanted further in person training.The patient was redirected to his physician.Additional information about any troubleshooting and outcome was requested.If received, a follow up report wil be sent.

Manufacturer Narrative

Concomitant medical products: product id: 97740, serial# (b)(4), implanted: (b)(6) 2014, product type: programmer, patient.Product id: 97791, lot# n443259, implanted: (b)(6) 2014, product type: accessory.Product id: 39565-65, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 97754, serial# (b)(4), product type: recharger.(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: 4270935
• MDR Text Key: 5253208
• Report Number: 3004209178-2014-22073
• 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: 11/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• 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: 12/04/2014
• Date Device Manufactured: 06/11/2014
• 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: 00055 YR