MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION RESUME TL; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 3986

Device Problems Unable to Obtain Readings (1516); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

The provided event information reasonably suggests the reported device pertained to one or both of the patient¿s implantable leads.A manufacturer¿s report was sent on each lead.See manufacturer¿s report # 3007566237-2016-00442 regarding the other implantable lead.Concomitant medical products: product id: 3986, serial# (b)(4), implanted: (b)(6) 1999, product type: lead.(b)(4).

Event Description

The consumer via the manufacturer representative reported that the patient experienced jolting sensations approximately at the lead location in the thoracic spine with stimulation turned up to the therapeutic voltage.The patient was also receiving appropriate stimulation down the legs, but the jolting sensation resulted in the patient not using stimulation.The event cause was unknown, and it was noted that the patient was a poor historian.Impedance checks revealed "???" on multiple combinations, and all other combinations were normal.The patient was reprogrammed with high-density-like settings.The implantable neurostimulator (ins) was at 45-90% use.It was also reported that revision of the full system was planned after testing.The patient's status was alive with no injury at the initial time of report.No outcome or troubleshooting/interventions were reported for this event.Further follow up is being conducted to obtain this information.If additional information becomes available, a follow up report will be sent.The patient's medical history included low back pain and multiple back operations.

• Brand Name: RESUME TL
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• 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: 5393078
• MDR Text Key: 36893769
• Report Number: 3007566237-2016-00444
• Device Sequence Number: 1
• Product Code: LGW
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3986
• Device Catalogue Number: 3986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/06/2016
• 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: 00054 YR