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

Model Number 97702

Device Problems Premature Discharge of Battery (1057); Failure to Deliver Energy (1211)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  Injury  

Event Description

The implantable neurostimulator (ins) was at end of service (eos), eos/eol message displayed.The longevity calculation was performed using the current settings and the ins was expected to last 26 months.Electrode impedance was performed and no shorts were noted, all in the 1000s.Group impedance was not done.The patient lost stimulation around christmas time but offices were closed.Average of 4v on both programs, 300pw and rate of 60.Program 1: 5,7+-; program 2: 57 13 14 15++--.The device was going to be explanted and replaced on (b)(6) 2015.The patient was in continuous mode.The patient was doing good and was receiving the therapy but she decided not to use it until the replacement.The company representative saw the patient on (b)(6) 2015 for a charging system orientation.The patient was feeling very good and have her new battery working properly.If additional information is received, a follow up report will be sent.

Manufacturer Narrative

Concomitant products: product id 977a260, serial# unknown, implanted: (b)(6) 2014, product type lead; product id 977a260, serial# unknown, product type lead.(b)(4).

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; 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: 4480412
• MDR Text Key: 5329289
• Report Number: 3004209178-2015-01662
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2014
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2015
• Date Device Manufactured: 06/27/2013
• 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