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

Model Number 97702

Device Problems Failure to Deliver Energy (1211); Vibration (1674)

Patient Problem Pain (1994)

Event Date 10/13/2014

Event Type  Injury  

Event Description

The patient complained of vibration and was admitted to the hospital today with severe pain.The patient wanted to have a company representative paged to shut off the device.The patient brought the patient programmer (pp) to the hospital.Upon interrogation, the stimulation off icon displayed.During the report, the reporter turned the device on and off to verify the off setting.After the reporter turned the stimulation off, the patient stated that the vibrating turned off.The pain remained after turning the device off.Additional information has been requested to find out if any troubleshooting or intervention was required and to obtain the outcome of this event.If additional information is received, a follow up will be sent.

Event Description

The patient health care provider (hcp) confirmed there was a 50% or greater symptom reduction.The cause of the event was determined and was not device related.Reprogramming was not needed.The patient did not experience a loss of therapeutic effect but did experience a sudden loss of stimulation.The patient did not realize how to turn the machine on.The patient has recovered without permanent impairment.

Manufacturer Narrative

Concomitant medical products: product id: 3550-29, lot# n471002, implanted: (b)(6) 2014, product type: accessory.Product id: 97740, serial# (b)(4), product type: programmer, patient.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.(b)(4).

Manufacturer Narrative

(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: 4221036
• MDR Text Key: 5002720
• Report Number: 3004209178-2014-20856
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2014
• Date Device Manufactured: 09/02/2014
• 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): Hospitalization
• Patient Age: 00072 YR