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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Event Description

It was reported that after a revision, the patient complained of electric like shocks when stimulation was turned up to the lowest level.An xray showed that both percutaneous leads were anterior.Impedance testing and reprogramming was done.The patient will be sent to a surgeon for surgical lead placement.The patient¿s status was alive with no injury.It was further reported that the patient¿s stimulator was off and they were doing fine.It was also stated the patient was advised to keep the stimulator recharged.See mfr 3004209178-2014-12868 for the previous revision mentioned.

Event Description

It was further stated by the surgeon that the patient was scheduled for a lead revision for a paddle lead (date not provided).The issue was considered ongoing.

Manufacturer Narrative

Concomitant products: product id 977a260, serial# unknown, implanted: (b)(6) 2014, product type lead; product id 97740, serial# (b)(4), product type programmer, patient; 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: 3933976
• MDR Text Key: 4572691
• Report Number: 3004209178-2014-13003
• 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
• Report Date: 06/25/2014

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: 12/28/2014
• 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: 07/15/2014
• Initial Date FDA Received: 07/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/06/2014
• Date Device Manufactured: 02/06/2014
• 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: 00051 YR