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

Model Number NEU_INS_STIMULATOR

Device Problems Electro-Static Discharge (2149); Device Operates Differently Than Expected (2913)

Patient Problem Heart Failure (2206)

Event Date 01/11/2018

Event Type  Injury  

Manufacturer Narrative

Literature citation: rueda, v.P., caceres jerez, l.E., gomezese, o.F.O., villalobos, m.P.G.Cases serie: refractory angina management with spinal cord stimulator.Experience at hospital internacional de colombia.Neuromodulation 2018; 21: e20.Doi: 10.1111/ner.12774.Please note the event date is based off of when the abstract was presented at the annual meeting of the north american neuromodulation society as the specific event date was not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the reported events with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.If information is provided in the future, a supplemental report will be issued.

Event Description

Literature summary: the refractory angina is defined as a chronic pathology characterized by the permanent pain or chest discomfort for longer than three months.The use of the spinal neuromodulation is one of the last therapeutic options, the objective to compare the evolution of the nyha functional class and the autonomy in daily life activities through the barthel scale in patients with refractory heart failure treated with an spinal neuromodulator from 2007 to 2017 at the hospital international de colombia (hic).After reviewing the medical records and applying the scales, a significant improvement was found in the functional class along with patient independence after the implantation of the spinal neuromodulator (sn).Reported event: it was reported the patient¿s device shut down after the patient was struck by lightning.It was further reported that this lead to ¿heart failure which was controlled by reprogramming a new sn.¿ the authors noted the event was an ¿unusual complication.¿ no further event information was reported; no further complications were reported or anticipated.See attached literature article.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR
• 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; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7664020
• MDR Text Key: 113250916
• Report Number: 3007566237-2018-01988
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• 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