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

Model Number 97714

Device Problem Communication or Transmission Problem (2896)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Event Description

It was reported that the lumbar stimulator indicated a discharge had occurred.The battery could not be interrogated due to the discharged state.The patient stated the lumbar battery had to be charged daily.The patient was running some high amplitude.The patient was able to get the recharging system to recharge.The patient was instructed to charge as soon as possible.It was further reported that the patient experienced a shocking sensation when the stimulator was on.This started about a month prior.The patient again stated he¿d had many falls and had scrapes on his knees.The patient¿s status was alive with no injury.See mfr# 3004209178-2014-12236 for a report of device issues with patient's second device.

Manufacturer Narrative

Concomitant medical products: product id 977a275, serial# (b)(4), implanted: (b)(6) 2014, product type: lead; product id 977a290, serial# (b)(4), implanted: (b)(6) 2014, product type: lead; product id 977a275, serial# (b)(4), implanted: (b)(6) 2014, product type: lead; product id 977a290, serial# (b)(4), implanted: (b)(6) 2014, product type: lead; product id 97714, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.(b)(4).

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Final device analysis for lead (serial: (b)(4)) revealed that the conductors were broken at the anchor site.The # 1, # 3, and # 5 conductors were broken 5.2 cm from the distal end.Final device analysis for the second lead (serial (b)(4)) revealed that the conductors were broken at the anchor site.The # 14 conductor was broken 6.1 cm from the distal end.The # 15 conductor was broken 5.2 cm from the distal end.Final device analysis for the stimulator revealed no significant anomalies.

Manufacturer Narrative

Concomitant medical products: product id 977a275, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id 977a290, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id 977a275, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id 977a290, serial# (b)(4), implanted: (b)(6) 2014, product type: lead.Product id 97714, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator.(b)(4).

Event Description

It was further clarified that serial (b)(4) was implanted in his right flank.Serial (b)(4) was the cervical pain device.The patient was getting more stimulation in his left arm than in his right, where he wanted the majority of coverage.When the implant (cervical) was interrogated, there were high impedances.However, the company representative was able to program around this and obtained great coverage in this right arm, right shoulder and neck.The patient was happy with this coverage.The shocking sensation was described as positional; the patient noticed it more when he sat extremely upright or turned his neck from side to side.The stimulation was programmed to gain coverage but not have the uncomfortable stimulation the patient referred to as shocking.The patients physician/staff were informed of the updates.

• 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: 3900774
• MDR Text Key: 4426657
• Report Number: 3004209178-2014-12238
• 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: 06/03/2014

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: 01/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 06/27/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/24/2014; 07/25/2014; 08/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2014
• 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: 00037 YR