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

Model Number 97714

Device Problems Charging Problem (2892); Communication or Transmission Problem (2896); Positioning Problem (3009)

Patient Problems Pain (1994); Swelling (2091); Discomfort (2330)

Event Date 07/03/2014

Event Type  Injury  

Event Description

It was stated that the repositioning was scheduled for (b)(6) 2014.

Event Description

It was reported that the patient was having difficulty getting the coupling boxes filled in.Compatibility was checked and the right recharger was being used.The company representative did not want to try too much as the patient just got her staples out and was tender and swollen near the implant.Antenna locate was reviewed.The stimulator battery was at about 3/4 charged.It was further reported that the recharger (insr) only showed all white bars and the patient could not get them to fill in.As noted, there was prior swelling and it hurt her at that time charge it due to being sore.The patient was able to turn the stimulator on and off with the recharger.The programmer also worked to adjust stimulation and turn it on and off.The battery was half full.A new recharger had not been sent, but one was requested.It was suggested that if a new recharger did not resolve the issue, implant depth or flipped status be checked via diagnostic imaging.It was further reported that a different recharger was used and the patient was unable to get any coupling bars.It was reviewed that the equipment was working.It was reviewed that the stimulator would still charge without coupling bars, but it would take much longer.The patient was advised to see her physician to diagnose the problem.It was further reported that the patient was seen and a different recharger was used with the same results.A consultation was being made to determine if the stimulator had flipped or was implanted too deep.The patient was doing well, but was not using her stimulator at this time as she did not want to deplete her battery.It was further reported that the patient was still awaiting a surgery consult date with the implanting physician as of (b)(6) 2014.It was further reported that the stimulator was not positioned correctly and it was being repositioned.It was stated that the patient had great stimulation relief despite the charging problems.It was stated that the battery was at 25%.The difference between discharge and overdischarge was discussed.

Manufacturer Narrative

Concomitant medical products: product id: 97754, serial# (b)(4), product type: recharger.Product id: 97792, lot# n389277, implanted: (b)(6) 2014, product type: accessory.Product id: 39565-65, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id: 97740, serial# (b)(4), product type: programmer, patient.(b)(4).

Event Description

It was further reported that the pocket revision was completed on (b)(6) 2014 as planned.The stimulator was discharged and needed charging.It was expected that the stimulator would charge normally.Additional information about the patients outcome was requested, if received a follow up report will be sent.

Event Description

It was reported the patient's stimulator was able to charge to twenty-five percent in the or.The patient was at home and using their stimulator for their left leg pain.

• 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: 4048597
• MDR Text Key: 16450087
• Report Number: 3004209178-2014-16145
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/25/2014

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: 04/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/05/2014
• Initial Date FDA Received: 08/29/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/03/2014; 09/09/2014; 09/10/2014
• Date Device Manufactured: 06/02/2014
• 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): Required Intervention
• Patient Age: 00037 YR