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

Model Number 97702

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2015

Event Type  Injury  

Event Description

Additional information received reported the patient was seen by the manufacturing representative and the eos message was confirmed.The patient¿s settings were not on cycling.The patient used the device 24/7 on amplitudes of 8.5 or above.The patient had used much lower settings during their trial.The patient was going to have a replacement but no surgery date was set as replacement was awaiting insurance approval.If additional information is received, a follow up report will be sent.

Event Description

The end of service/end of life (eos/eol) message was seen today for the first time.The doctor told the patient his battery would last for a long time but his implantable neurostimulator (ins) was implanted in (b)(6) 2014.The patient thought it would last three years, but only lasted six months.Appointment dates of (b)(6) 2015 were noted.The patient needs to get a new battery.Additional information has been requested to find out if any intervention or troubleshooting was required and to obtain the outcome of this event.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant products: product id 97740, serial # (b)(4), product type programmer, patient; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 977a260, serial # (b)(4), implanted: (b)(6) 2014, product type lead.(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: 4599036
• MDR Text Key: 5620008
• Report Number: 3004209178-2015-04687
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2015
• Date Device Manufactured: 08/11/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 00087 YR