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 Therapeutic Response, Decreased (2271)

Event Date 05/27/2015

Event Type  Injury  

Event Description

It was reported the patient saw an elective replacement indicator (eri) message on their device and despite changing the batteries in their patient programmer could not clear the message.It was later confirmed that the patient¿s device had reached end of service (eos) within 6 months.The impedances were within normal limits.Using two programs, two cathodes and two anodes were on each program.The amplitude was set to 6.1v, the pulse width at 450us and a rate of 60hz.The patient used their stimulation approximately 14 hours per day and had good coverage.As a result of the eos, the patient had less than 50% therapy relief in their legs.The patient believed their unit was defective as they thought the eos was premature.The patient had their battery replaced with a rechargeable unit.There were no issues seen during the replacement surgery.After the replacement the patient¿s device was turned on and they were receiving coverage in their needed areas.

Manufacturer Narrative

Concomitant products: product id 977a160, serial # (b)(4), implanted: (b)(6) 2014, product type lead; product id 97740, serial # (b)(4), product type programmer, patient; product id 977a160, serial # (b)(4), implanted: (b)(6) 2014, product type lead.(b)(4).

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Manufacturer Narrative

Analysis of the implantable neurostimulator (s/n (b)(4)) found no significant anomaly.

Event Description

No new information was reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 4850483
• MDR Text Key: 5810580
• Report Number: 3004209178-2015-11761
• 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: Other,Consumer,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2014
• 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: 00066 YR